FDA 510(k) Applications for Medical Device Product Code "FPA"
(Set, Administration, Intravascular)

FDA 510(k) Number Applicant Device Name Decision Date
K153731 410 Medical Innovation, LLC LifeFlow Rapid Infusion Device (LifeFlow Device) 08/25/2016
K191362 410 Medical, Inc. LifeFlow Blood System 05/20/2020
K984569 AB2 MEDICAL PRODUCTS, LLP AB2 MED-FLO SOLUTION SET 08/12/1999
K954283 ABBOTT LABORATORIES ENERGIZED CONTAINER SYSTEM (MODIFICATION) 05/29/1996
K002006 ABBOTT LABORATORIES LIFESHIELD ADDITIVE PIERCING PIN 08/10/2000
K033576 ABBOTT LABORATORIES LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE 12/04/2003
K030002 ABBOTT LABORATORIES LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. 01/27/2003
K955410 ABBOTT LABORATORIES SNAPDOSE DEVICE 05/06/1996
K971293 ABBOTT MFG., INC. LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE 06/27/1997
K103165 ACACIA, INC. BLOOD SAMPLING SET 11/10/2010
K142527 ACACIA, INC. Extension Set with BD Q-Syte Luer Access Split Septum 09/19/2014
K990693 ACT MEDICAL, INC. FLEXNEEDLE PLUS 05/14/1999
K121803 ACTA MEDICAL LLC INTRAVASCULAR ADMINISTRATION SET 12/19/2012
K022209 ALARIS MEDICAL SYSTEMS, INC. ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS 08/06/2002
K220267 Amsino International, Inc. AMSafe NeuFlo Needleless Connector 10/07/2022
K173665 Amsino International, Inc. AMSafe Sure-Lok Needle-Free Connector 09/05/2018
K101958 AMSINO INTERNATIONAL, INC. AMSINO I.V. ADMINISTRATION AND EXTENSION SETS 09/29/2010
K093773 AMSINO INTERNATIONAL, INC. AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS 03/10/2010
K973107 AMSINO INTL., INC. AMSINO I.V. ADMINISTRATION SET 10/02/1997
K092905 ANALYTICA PTY LTD AUTOSTART BURETTE 03/04/2010
K051142 ANGIODYNAMICS, INC. ANGIODYNAMICS TUMESCENT INFUSION DEVICE 07/13/2005
K953825 ANGIODYNAMICS, INC. ANGIOFLUSH II FLUID MANAGEMENT SYSTEM 02/26/1996
K072375 ANGIODYNAMICS, INC. SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET 12/13/2007
K083687 ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. BAIXIN INTRAVASCULAR ADMINISTRATION SET 06/11/2009
K191640 Anhui Tiankang Medical Technology Co.,Ltd. TK Intravascular Administration Set 08/26/2020
K012754 ANIMAS CORP. EZ SET INFUSION SET 08/27/2001
K033099 APPLIED DIABETES RESEARCH, INCORPORATED ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 10/16/2003
K012429 APPLIED DIABETES RESEARCH, INCORPORATED SURESET INFUSION SET, MODEL 8023 11/06/2001
K023769 APPRO HEALTHCARE, INC. PREPARE ADMINISTRATION SET 12/30/2002
K953746 ARROW INTL., INC. ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET 01/26/1996
K190806 ASSET MEDIKAL TASARIM A.S. Flowart 02/20/2020
K221473 Asset Medikal Tasarim AS. Flowart 09/26/2022
K201872 Asset Medikal Tasarim AS. NeutrArt 01/05/2021
K221481 Asset Medikal Tasarim AS. NeutrArt 09/23/2022
K222889 Asset Medikal Tasarim San Tic As. FlowArt« Needle-Free Split Septum Valve 01/20/2023
K030137 AVAIL MEDICAL PRODUCTS, INC. MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9 02/19/2003
K030149 AVAIL MEDICAL PRODUCTS, INC. MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 03/20/2003
K153293 B. BRAUN MEDICAL INC. Extension Set 04/06/2016
K170595 B. Braun Medical Inc. IV Administration Sets 11/07/2017
K202618 B. Braun Medical Inc. IV Administration Sets 09/24/2021
K143082 B. Braun Medical Inc. IV Administration Sets with 200(micro)m Blood Filter 07/24/2015
K191658 B. Braun Medical Inc. IV Sets not made with PVC 03/19/2020
K212842 B. Braun Medical Inc. Microvolume Luer Access Device 01/18/2022
K083723 B. BRAUN MEDICAL, INC. A6 LUER ACCESS DEVICE 06/05/2009
K073396 B. BRAUN MEDICAL, INC. ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG 08/07/2008
K140311 B. BRAUN MEDICAL, INC. CARESITE LUER ACCESS DEVICE 05/07/2014
K052252 B. BRAUN MEDICAL, INC. CONTRAST MEDIA TRANSFER SETS 11/16/2005
K112636 B. BRAUN MEDICAL, INC. CYTOGUARD(TM) CLOSED LUER CONNECTOR 11/26/2011
K142036 B. BRAUN MEDICAL, INC. INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS 08/25/2014
K140838 B. BRAUN MEDICAL, INC. IV ADMINISTRATION SET WITH HAND PUMP 12/05/2014
K041490 B. BRAUN MEDICAL, INC. IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING 10/29/2004
K021488 B. BRAUN MEDICAL, INC. SURECAN SAFETY HUBER NEEDLE INFUSION SETS 07/08/2002
K031923 B. BRAUN MEDICAL, INC. ULTRASITE VALVE 08/11/2003
K955585 B. BRAUN MEDICAL, INC. V2 INJECTION SITE 05/15/1996
K974145 B. BRAUN MEDICAL, INC. V3 VALVE 01/06/1998
K173361 B.Braun Medical Inc. IV Administration Set 06/26/2018
K213778 B.Braun Medical Inc. IV Administration Set 03/03/2022
K062909 BAXA CORP. REPEATER PUMP II TUBE SETS 03/09/2007
K984381 BAXTER HEALTHCARE CORP. BURETROL SOLUTION SETS 02/19/1999
K072576 BAXTER HEALTHCARE CORP. CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED 11/06/2007
K982672 BAXTER HEALTHCARE CORP. COLLEAGUE PUMP SYRINGE ADAPTER SET 09/04/1998
K971701 BAXTER HEALTHCARE CORP. CONTINU-FLO SOLUTION SET 06/06/1997
K961225 BAXTER HEALTHCARE CORP. CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET 06/21/1996
K981318 BAXTER HEALTHCARE CORP. DUAL LUER LOCK CAP 04/22/1998
K101385 BAXTER HEALTHCARE CORP. DUAL LUER LOCK CAP, MODEL 2C6250 06/22/2010
K121092 BAXTER HEALTHCARE CORP. FLOWEASE [SUBCUTANEOUS] INFUSION SET 06/29/2012
K961495 BAXTER HEALTHCARE CORP. HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE 06/26/1996
K962893 BAXTER HEALTHCARE CORP. INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE 10/18/1996
K970438 BAXTER HEALTHCARE CORP. INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS 04/02/1997
K103551 BAXTER HEALTHCARE CORP. INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, 03/25/2011
K123874 BAXTER HEALTHCARE CORP. INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S 01/10/2013
K123868 BAXTER HEALTHCARE CORP. INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET 01/08/2013
K060074 BAXTER HEALTHCARE CORP. INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 03/29/2006
K984060 BAXTER HEALTHCARE CORP. LUER ACCESS INJECTION SITE 07/26/1999
K132734 BAXTER HEALTHCARE CORP. NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS 10/08/2013
K981792 BAXTER HEALTHCARE CORP. SOLUTION ADMINISTRATION SET 08/17/1998
K964850 BAXTER HEALTHCARE CORP. SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER 02/25/1997
K974571 BAXTER HEALTHCARE CORP. SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE 05/21/1998
K003225 BAXTER HEALTHCARE CORP. SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE 10/19/2000
K042936 BAXTER HEALTHCARE CORP. SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE 11/26/2004
K081289 BAXTER HEALTHCARE CORP. V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE 08/04/2008
K112893 BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS 10/18/2011
K180739 Baxter Healthcare Corporation Clearlink System Solution Set 05/28/2019
K121634 BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR 06/29/2012
K203609 Baxter Healthcare Corporation Intravascular Administration Sets 09/30/2021
K210430 Baxter Healthcare Corporation Intravascular Extension Set 06/18/2021
K192366 Baxter Healthcare Corporation Intravascular Extension Sets and Accessories 07/20/2020
K172544 Baxter Healthcare Corporation IV Fat Emulsion Administration Sets 09/22/2017
K150860 BAXTER HEALTHCARE CORPORATION Nitroglycerin Sets with DUO-VENT Spike 04/16/2015
K160007 BAXTER HEALTHCARE CORPORATION Paclitaxel Sets 12/19/2016
K212262 Baxter Healthcare Corporation PCA Syringe Sets 10/03/2022
K153158 BAXTER HEALTHCARE CORPORATION Solution Administration Sets with 0.2 Micron Filter 12/28/2015
K161323 BAXTER HEALTHCARE CORPORATION Solution Set for Epidural Use 11/30/2016
K161808 Baxter Healthcare Corporation Solution Set with 1.2 Micron Air Eliminating Filter 06/21/2017
K142011 BAXTER HEALTHCARE CORPORATION SOLUTION SET/EXTENSION SET 08/18/2014
K120443 BAXTER HEALTHCARE CORPORATION - RENAL DIVISION NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE 05/22/2012
K011858 BD INTERLINK THREADED LOCK CANNULA 06/19/2001
K033350 BECTON DICKINSON & CO. BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER 11/18/2003
K050207 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD POSIFLOW POSITIVE DISPLACEMENT VALVE 04/07/2005
K013621 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 04/16/2002
K970259 BECTON DICKINSON VASCULAR ACCESS, INC. E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET 04/08/1997
K153257 BECTON, DICKINSON AND COMPANY BD FlowSmart Set, MiniMed Pro-Set 12/11/2015
K160651 BECTON, DICKINSON AND COMPANY BD FlowSmart Set, MiniMed Pro-Set 04/07/2016
K181718 Becton, Dickinson and Company BD FlowSmart Set/MiniMed Pro-Set 10/18/2018
K150059 BECTON, DICKINSON COMPANY BD FlowSmart Set 04/28/2015
K161898 BEIJING FERT TECHNOLOGY CO., LTD Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set 03/08/2017
K112799 BENLAN INC MED-RX EXTENSION SET WITH T-CONNECTOR 12/23/2011
K120375 BENLAN INC MED-RX PATIENT DELIVERY SET 06/28/2012
K990777 BENLAN, INC. MED-RX EXTENSION SETS 08/25/1999
K102073 BENLAN, INC. MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS 11/08/2010
K971500 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER 08/18/1997
K961327 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES BEC NEEDLELESS INJECTION SITE 05/15/1996
K962801 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES SAFE MATE I.V. EXTENSION SETS 08/28/1996
K962802 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES SAFE MATE I.V. FLUID DELIVERY SETS 08/28/1996
K961928 BIOMEDIX, INC. BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 09/16/1996
K142097 BIOMEDIX, INC. SELEC-3 I.V.ADMINISTRATION SET 08/29/2014
K011216 BIOMETRIX LTD. PVC FREE INTRAVASCULAR ADMINISTRATION SET 07/18/2001
K002449 BIOTEQUE CORP. BIOTEQ I.V. (INTRAVENOUS) SET 12/22/2000
K012526 BIOTEQUE CORP. BIOTEQUE SCALP VEIN SET 09/14/2001
K964439 BMW MEDICAL, INC. NEEDLE-FREE VALVED CONNECTOR AND CAP 07/16/1997
K223645 BQ PLUS Medical Co., Ltd I.V. Administration Set, I.V. Extension Set 05/18/2023
K210381 BQ PLUS Medical Co., Ltd. I.V. Administration Set 08/14/2021
K141285 BUSSE HOSPITAL DISPOSABLES BUSSE EXTENSION SET 02/19/2015
K153440 C.R BARD, INC. PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set 08/18/2016
K102405 C.R. BARD, INC. INFUSION SET FOR POWERPICC SOLO 2 CATHETER 07/21/2011
K090134 C.R. BARD, INC. INTRAVENOUS POWER INJECTOR EXTENSION SET 04/21/2009
K082306 C.R. BARD, INC. POWERLOC CLEAR SAFETY INFUSION SET 08/28/2008
K171118 Cair L.G.L Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) 08/15/2017
K171117 Cair L.G.L Carefusion NeutraClear Needle-free connector (EL-NC1000) 09/01/2017
K133073 CAIR LGL CAIR DRIVE, NEUTRACLEAR 03/20/2014
K171132 CAIR LGL Carefusion NeutraClear Needle-free connector 07/31/2017
K053049 CARDINAL HEALTH, ALARIS PRODUCTS ALARIS SAFETY MALE LUER 01/12/2006
K061285 CARDINAL HEALTH, ALARIS PRODUCTS SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS 07/26/2006
K021080 CARDIOMED SUPPLIES, INC. NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS 08/29/2002
K221327 CareFusion BD AlarisÖ Pump Infusion Sets 07/21/2023
K223101 CareFusion BD Secondary Infusion Set 05/12/2023
K223088 CareFusion BD SmartSiteÖ Needle-Free Connector 04/07/2023
K143234 CAREFUSION MaxZero Administration Sets 11/20/2014
K140831 CAREFUSION MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR 04/15/2014
K132413 CAREFUSION MZ1000 08/29/2013
K171957 Carefusion 303 Inc. MaxZero Extension Sets with Needless Connector 07/19/2017
K193088 Carefusion, Inc. MaxZero Extension Sets with Needle-Free Connector(s) 10/23/2020
K980127 CATHETER INNOVATIONS, INC. 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT 03/11/1998
K042129 CEDIC S.R.L. F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK 01/27/2005
K103562 CENTURION MEDICAL PRODUCTS CORPORATION CENTURION PRESSURE INJECTABLE EXTENSION SET 06/23/2011
K021395 CHURCHILL MEDICAL SYSTEMS, INC. MODIFICATION TO 30 EXTENSION SET 05/13/2002
K011888 CHURCHILL MEDICAL SYSTEMS, INC. PRESSURE ACTIVATED CHECK VALVE 09/10/2001
K011336 CHURCHILL MEDICAL SYSTEMS, INC. PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK 06/12/2001
K013949 CHURCHILL MEDICAL SYSTEMS, INC. UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR 03/27/2002
K013950 CHURCHILL MEDICAL SYSTEMS, INC. VENTED VIAL ACCESS DEVICE 01/10/2002
K020544 CHURCHILL MEDICAL SYSTEMS, INC. WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA 03/12/2002
K041919 CLINICO PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606 10/04/2004
K981157 CMED STABLE FLOW 06/16/1998
K013714 CODAN US CORP. CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP 03/28/2002
K021480 CODAN US CORP. EXTENSION SET LIGHT-SAFE, MODEL BC565 06/27/2002
K001872 CODAN US CORP. I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 09/07/2000
K033301 CODAN US CORP. IV ADMINISTRATION AND CONNECT SETS 03/04/2004
K042693 CODAN US CORP. IV ADMINISTRATION SET B400 SP 10/21/2004
K033515 COMMAND MEDICAL PRODUCTS HUBERPRO SAFETY HUBER INFUSION SET 01/22/2004
K964844 CONMED CORP. CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS 03/24/1997
K083482 COOK VASCULAR INC. COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET 04/02/2009
K991985 COOK, INC. COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET 08/20/1999
K983217 COOK, INC. ROWE DUAL-CHECK VALVE 01/20/1999
K001106 CREATIVE PLASTIC TECHNOLOGY MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 08/16/2000
K983926 CRITICAL DEVICE CORP. MPS GRAVITY FLOW CONTROL SET 01/20/1999
K952852 CRITICAL DEVICE CORP. NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET 02/16/1996
K964812 CRITICAL DEVICE CORP. NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET 02/10/1997
K964918 CRITICAL DEVICE CORP. NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS 04/14/1997
K993463 CUSTOM ASSEMBLIES, INC. INTRAVASCULAR ADMINISTRATION SET 01/04/2000
K140175 DELTA MED SPA INTRAVASCULAR ADMINISTRATION SET 08/05/2014
K031361 DELTEC, INC. CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP 05/23/2003
K021999 DELTEC, INC. GRIPPER PLUS NEEDLE 08/13/2002
K060488 DERMATECH MEDICAL INC DERMATECH IV HOLDER 06/08/2006
K992999 DIASOL, INC. DAISY PROTECTED SCALP VEIN SET 11/05/1999
K011003 DIASOL, INC. SAFESTING AND SAFESTING HUB 04/20/2001
K993187 DIASOL, INC. SHELLY PROTECTED AV FISTULA NEEDLE 11/05/1999
K070189 DISETRONIC MEDICAL SYSTEMS AG ACCU-CHEK ULTRAFLEX INFUSION SET 02/21/2007
K003977 DISETRONIC MEDICAL SYSTEMS AG DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET 02/15/2001
K033892 DISETRONIC MEDICAL SYSTEMS AG ULTRAFLEX INFUSION SET 03/09/2004
K954983 DISTRONIC STERILE PRODUCTS, INC. EXTENSION SET WITH CHECK VALVE 01/23/1996
K955732 DISTRONIC STERILE PRODUCTS, INC. VENTED SOLUTION SET 02/21/1996
K955709 DISTRONIC STERILE PRODUCTS, INC. WINGED & SUBCUTANEOUS INFUSION SETS 02/21/1996
K043328 DKS LOVERSAN INDUSTRIA BIOMEDICA SPA MICROFLO-SAFE SCALP VEIN SET 04/15/2005
K162951 Douglas Medical Products, Inc. TUBETECH IV Administration Set 07/28/2017
K043235 DRAGON HEART MEDICAL DEVICES CO., LTD. DRAGON HEART I.V. SET 03/08/2005
K101368 DRAGON HEART MEDICAL, INC. D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES 11/18/2010
K111016 ELCAM MEDICAL A.C.A.L. SAFEPORT MANIFOLD (TM) (OR STOPCOCK) 06/09/2011
K140133 EMED TECHNOLOGIES CORPORATION INFUSET FLOW CONTROL EXTENSION SET 05/15/2014
K140131 EMED TECHNOLOGIES CORPORATION SUB-Q SUBCUTANEOUS TISSUE INFUSION SET 04/03/2014
K123729 EMED TECHNOLOGIES CORPORATION VERSARATE FLOW RATE CONTROLER 12/21/2012
K201626 Epic Medical Pte. Ltd. Safety Subcutaneous Infusion Set 03/24/2021
K020926 EPIMED INTERNATIONAL, INC. EXTENSION SET, MODELS 1911-512 07/12/2002
K020530 EVANS MEDICAL, INC. EVANS SUB-Q, MODEL MC4206 04/29/2002
K963659 EXEL INTL. EXEL I.V. ADMINISTRATION SET 12/16/1997
K992290 EXEL INTL. EXEL INJECTION PLUG WITH CAP 02/23/2000
K020189 EXELINT INTERNATIONAL CO. EXEL BUTTERFLY SCALP VEIN SET 03/27/2003
K010197 EXELINT INTERNATIONAL CO. EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET 05/14/2001
K031500 EXELINT INTL. CO. EXCEL PRIMARY SOLUTION SET 07/25/2003
K012879 EXELINT INTL. CO. EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE 01/17/2002
K010404 EXELINT INTL. CO. EXEL I.V. ADMINISTRATION SET 08/30/2001
K092172 EXELINT INTL. CO. EXEL I.V. EXTENSION SET 01/04/2010
K011405 EXELINT INTL. CO. EXEL INJECTION PLUG WITH CAP 09/27/2001
K020533 EXELINT INTL. CO. EXEL VACULET BLOOD COLLECTION SET 12/02/2002
K970524 FAULDING MEDICAL DEVICE CO. SAFE-CONNECT I.V. EXTENSION SET 04/22/1997
K970909 FAULDING MEDICAL DEVICE CO. SAFE-CONNECT I.V. SET 05/06/1997
K971266 FAULDING MEDICAL DEVICE CO. SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 05/01/1997
K955775 FAULDING MEDICAL DEVICE CO. SAFECONNECT VALVE (CATALOG NO. XXXX) 11/15/1996
K981548 FILTERTEK, INC. NFC NEEDLEFREE CONNECTOR MODEL 69900 06/18/1998
K981547 FILTERTEK, INC. NFC NEEDLEFREE Y-SITE, MODEL 69970 06/18/1998
K220301 Fresenius Kabi Volumat Line 06/02/2023
K221121 Fresenius Kabi Volumat Polyethylene I.V. Administration Set 06/16/2023
K041042 FRESENIUS MEDICAL CARE NORTH AMERICA SPLIT SEPTUM INJECTION SITES 07/16/2004
K082027 GENESIS BPS LLC FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160 02/13/2009
K972839 GLOBE ENT., INC. PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET 12/17/1997
K972854 GLOBE ENT., INC. PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY 12/17/1997
K992145 GREINER MEDITECH, INC. ECOMED SCALP VEIN SET 10/14/1999
K061115 GVS SPA SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 06/30/2006
K021916 HARMAC MEDICAL PRODUCTS, INC. HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 08/29/2002
K060352 HEALTH LINE INTERNATIONAL CORPORATION HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS 05/31/2006
K120548 HEALTH LINE INTERNATIONAL CORPORATION HLIC NEEDLE-LESS VALVE 05/04/2012
K070630 HEALTH LINE INTERNATIONAL CORPORATION (HLIC) HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE 08/31/2007
K020424 HENNIG ENTERPRISES EUROPE S.R.L. V SET 08/29/2003
K013871 HORIZON MEDICAL PRODUCTS, INC. LIFEGUARD SAFETY INFUSION SET 03/29/2002
K142974 Hospira, Inc Extension Sets 01/09/2015
K160870 HOSPIRA, INC. Hospira Administration Sets 06/01/2016
K143087 HOSPIRA, INC. Hospira Blood Set 03/04/2015
K142433 Hospira, Inc. Hospira Extension Set 12/08/2014
K161036 HOSPIRA, INC. Hospira Extension Set, Hospira Primary Set 01/06/2017
K101677 HOSPIRA, INC. HOSPIRA INFUSION BLOOD SETS 08/11/2010
K103224 HOSPIRA, INC. HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING 01/07/2011
K142367 HOSPIRA, INC. Hospira Primary Sets 11/25/2014
K143015 Hospira, Inc. Hospira Primary Sets 02/25/2015
K103344 HOSPIRA, INC. INFUSION SETS 12/10/2010
K142622 HOSPIRA, INC. IV Administration 01/15/2015
K052722 HOSPIRA, INC. LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS 11/02/2005
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K021005 STERLING MEDIVATIONS, INC. SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE 04/25/2002
K014062 STERLING MEDIVATIONS, INC. SIMPLICITY EASY ACCESS INFUSION SET 01/17/2002
K021487 STERLING MEDIVATIONS, INC. SIMPLICITY EASY ACCESS P INFUSION SET 05/17/2002
K021530 STERLING MEDIVATIONS, INC. SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN 05/21/2002
K020912 STERLING MEDIVATIONS, INC. SIMPLICITY EASY SOFT INFUSION SET 04/10/2002
K012330 STERLING MEDIVATIONS, INC. SIMPLICITY EURO QD INFUSION SET 08/10/2001
K010647 STERLING MEDIVATIONS, INC. SIMPLICITY INFUSER INFUSION SET 04/13/2001
K021296 STERLING MEDIVATIONS, INC. SIMPLICITY QD EASY P INFUSION SET 05/14/2002
K013104 STERLING MEDIVATIONS, INC. SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE 10/02/2001
K010846 STERLING MEDIVATIONS, INC. SIMPLICITY SILVER SET SOFT INFUSION 04/12/2001
K020629 STERLING MEDIVATIONS, INC. SIMPLICITY SIMPLEX SOFT INFUSION SET 04/01/2002
K002492 STERLING MEDIVATIONS, INC. SIMPLICITY SOFT INFUSION SET 10/24/2000
K010788 STERLING MEDIVATIONS, INC. SIMPLICITY SOFT QD EASY INFUSION SET 04/20/2001
K020990 STERLING MEDIVATIONS, INC. SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN 04/10/2002
K012845 STERLING MEDIVATIONS, INC. SIMPLICITY SOFT QD MICRO INFUSION SET 09/14/2001
K011580 STERLING MEDIVATIONS, INC. SIMPLICITY SOFT QD SILVER INFUSION SET 06/05/2001
K010373 STERLING MEDIVATIONS, INC. SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) 03/13/2001
K011187 STERLING MEDIVATIONS, INC. SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS 06/19/2001
K014061 STERLING MEDIVATIONS, INC. SIMPLICITY STARPLUS SOFT INFUSION SET 01/17/2002
K010886 STERLING MEDIVATIONS, INC. SIMPLICITY WING INFUSION SET 04/30/2001
K010676 STERLING MEDIVATIONS, INC. SIMPLICITY WINGED QD INFUSION SET 04/18/2001
K003283 STERLING MEDIVATIONS, INC. SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103) 12/13/2000
K021216 STERLING MEDIVATIONS, INC. SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS 05/03/2002
K960391 STRATO/INFUSAID, INC. STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 07/03/1996
K971066 TAMARYN MEDICAL SYSTEMS, INC. TAMARYN I.V. FLOW REGULATOR EXTENSION SET 06/04/1997
K031266 TERUMO CORP. SURSHIELD SAFETY WINGED INFUSION SET 05/30/2003
K100946 TERUMO EUROPE N.V. INTRAVSCULAR ADMINISTRATION SET 08/02/2010
K070362 TERUMO EUROPE N.V. SURFLO WINGED INFUSION SET 05/07/2007
K133894 TERUMO EUROPE N.V. SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) 03/18/2014
K070547 TERUMO EUROPE N.V. SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) 05/25/2007
K133867 TERUMO EUROPE N.V. SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) 02/05/2014
K072894 TERUMO EUROPE N.V. SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) 11/06/2007
K052887 TERUMO EUROPE N.V. SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS 12/08/2005
K013164 TERUMO MEDICAL CORP. SURSHIELD SAFETY WINGED BLOOD COLLECTION SET 10/15/2001
K010103 TERUMO MEDICAL CORP. SURSHIELD WINGED INFUSION SET 03/15/2001
K221411 Terumo Medical Products (Hangzhou) Co., Ltd. Surflo Winged Infusion Set 06/23/2023
K031279 TERUMO MEDICAL PRODUCTS HANGZHOU CO., LTD. SURSHIELD SAFETY WINGED BLOOD COLLECTION SET 05/30/2003
K141306 TEVA MEDICAL LTD., MIGADA PLANT TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE 06/12/2014
K990288 TEVA MEDICAL, LTD. FREE FLOW SAFETY DEVICE, MODEL MG 245052 02/24/1999
K993147 THE KIPP GROUP DECAP 11/02/1999
K991932 THE KIPP GROUP INTRAVASCULAR ADMINISTRATION SET 08/20/1999
K970255 THE KIPP GROUP KIPP MED I.V. MANIFOLD 04/14/1997
K000152 THE KIPP GROUP KIPPMED I.V. MANIFOLD 02/29/2000
K992268 THE KIPP GROUP NAC PRN NEEDLELESS ACCESS CONNECTOR 09/15/1999
K000343 THE KIPP GROUP NAC Y-ADP 03/01/2000
K060082 TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD. TIANJIN MEDIS DISPOSABLE INFUSION SET 03/31/2006
K990331 TIVA MEDICAL SURGEN VALVE 05/31/2000
K972663 TOPSPINS, INC. SMART SET 09/02/1997
K151250 TOPSPINS, INC. Smart Set 06/07/2016
K073444 TRITON MEDICAL, LLC TRITON MEIDCAL TMED IV-SET 08/18/2008
K023595 TUTA HEALTHCARE PTY LIMITED BURETTE-IN LINE (150 ML) 12/18/2002
K151151 U & U Medical Technology Co., Ltd U & U Intravascular Administration Set 09/24/2015
K080660 U.S. SAFETY SYRINGES CO., INC. IV ADMINISTRATION SET 05/13/2008
K080665 U.S. SAFETY SYRINGES CO., INC. NOVOLET 05/13/2008
K964968 UNIVERSITY OF MICHIGAN MR EXTENSION SET (001) 02/27/1997
K040633 UNOMEDICAL A/S CLICK-ON 04/01/2004
K051264 UNOMEDICAL A/S COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS 09/01/2005
K041545 UNOMEDICAL A/S CONTACT DETACH 06/30/2004
K061374 UNOMEDICAL A/S INTUITION INFUSION SETS 07/31/2006
K210544 Unomedical A/S Medtronic Extended infusion set 07/16/2021
K173879 Unomedical A/S MiniMed Mio Advance infusion set 03/05/2018
K160648 UNOMEDICAL A/S MiniMed Quick-Set« MiniMed Sure-T« MiniMed Silhouette« MiniMed Mio« 08/10/2016
K192647 Unomedical a/s neria guard Infusion Set 12/13/2019
K132142 UNOMEDICAL A/S NERIA SOFT 90 INFUSION SET 10/08/2013
K070430 UNOMEDICAL A/S PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS 04/04/2007
K162812 UNOMEDICAL A/S Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roc 11/01/2017
K032854 UNOMEDICAL A/S UNOMEDICAL MONICA INFUSION SET 10/09/2003
K120872 UNOMEDICAL A/S INFUSION DEVICES ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS 04/20/2012
K120395 UNOMEDICAL DEVICES S.A DE C.V NERIA MULTI SUBCUTANEOUS INFUSION SET 05/30/2012
K111351 US INFUSION DBA TRUECARE BIOMEDIX TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET 09/29/2011
K983411 VALNET MEDICAL CORP. COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105 02/09/1999
K200439 Velano Vascular Velano ExT Extension Set 02/23/2021
K182897 Velano Vascular Velano Vascular Q2 Extension Set 03/26/2019
K980994 VENETEC INTL., INC. IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES 05/29/1998
K980992 VENETEC INTL., INC. IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES 05/28/1998
K981683 VENUSA LTD. HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y 07/28/1998
K994429 VENUSA LTD. VENUSA, LTD. EXTENSION SET WITH FILTER 03/03/2000
K093271 VICTUS, INC. EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD 01/27/2010
K023469 VICTUS, INC. VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062 12/10/2002
K030246 VICTUS, INC. VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072 02/26/2003
K061771 VIDACARE CORPORATION EZ-CONNECT 07/10/2006
K050906 VITALCARE GROUP, INC. VITALCARE I.V. ADMINISTRATION SET 08/23/2005
K972957 VLV ASSOCIATES, INC. SA-EF MULTI-LUMEN EXTENSION SET 09/29/1997
K964876 VLV ASSOCIATES, INC. SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET 02/28/1997
K955783 VLV ASSOCIATES, INC. VLV SA.EF INFUSION PORT EXTENSION SETS 02/07/1996
K963981 VYGON CORP. VYGON BIONECTOR WITH EXTENSION SET 02/14/1997
K964067 W.L. GORE & ASSOCIATES,INC GORE IRRIGATION SET 06/05/1997
K954823 WINFIELD INDUSTRIES VENIPUNCTURE KIT 01/30/1996
K181870 Wuhan W.E.O Science & Technology Development Co., Ltd. Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use 02/26/2019
K960280 Y IVAC NEEDLE FREE VALVE ADMINISTRATION SETS 04/04/1996
K230992 Yangzhou Wei De Li Trade Co. Ltd DJF Intravascular Administration Set 06/09/2023
K130468 YPSOMED AG ORBIT INFUSION SET 03/19/2013
K150921 YPSOMED AG Orbit Infusion Set 04/12/2016
K171101 Yukon Medical Closed Male Luer 06/02/2017
K120799 YUKON MEDICAL, LLC ARISURE NEUTRAL VALVE 03/30/2012
K120685 ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET 09/07/2012
K132841 ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET 01/23/2014


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