FDA 510(k) Applications for Medical Device Product Code "FOZ"
(Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days)

FDA 510(k) Number Applicant Device Name Decision Date
K953805 ABBOTT LABORATORIES 0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE 06/28/1996
K961552 ABBOTT LABORATORIES CVP POLYURETHANE CATHETER 02/10/1997
K001616 ABBOTT LABORATORIES MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE 07/27/2000
K203069 Access Vascular Inc. HydroMID 02/08/2021
K220772 Access Vascular, Inc. HydroMID 4F Single Lumen Midline Catheter 12/07/2022
K981905 ACU-PAK STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 08/18/1998
K073471 ADVANTAGE MEDICAL DEVICE VANTAGECATH INTRAVASCULAR CATHETER 04/30/2008
K970644 AEROQUIP MEDICAL PRODUCTS AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM 07/31/1997
K970669 AEROQUIP MEDICAL PRODUCTS AEROQUIP SAFESTART IV CATHETER 08/01/1997
K032417 AM2 PAT INC. HEPARIN LOCK FLUSH SYRINGE 12/23/2003
K110794 AMECO MEDICAL INDUSTRIES AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS 12/21/2011
K073520 ANGIOTECH PHARMACEUTICALS, INC. ANGIOTECH CVC 04/11/2008
K151513 Arrow Internation, Inc. (subsidiary of Teleflex Inc.) Arrow Endurance Extended Dwell Peripheral Catheter System 07/08/2015
K150109 Arrow International ( a subsidiary of Teleflex, Inc.) Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology 06/05/2015
K071538 ARROW INTERNATIONAL, INC. ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER 08/30/2007
K152272 ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) Arrow Endurance Extended Dwell Peripheral Catheter System 11/23/2015
K163513 Arrow International, Inc. (subsidiary of Teleflex Inc.) Arrow Endurance Extended Dwell Peripheral Catheter System 02/24/2017
K032962 ARROW INTL., INC. AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE 10/29/2003
K970864 ARROW INTL., INC. ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS 10/17/1997
K993691 ARROW INTL., INC. ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER 03/08/2000
K962577 ARROW INTL., INC. ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER 08/21/1997
K003187 AUTO/CATH VASCULAR ACCESS, INC. VACUCATH I.V. CATHETER INTRODUCTER 05/21/2001
K000632 AVITRO LLC. 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE 10/19/2000
K001795 AVITRO LLC. THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD 10/19/2000
K213664 B. Braun Medical Inc. B. Braun Introcan Safety 2 IV Catheter 02/11/2022
K192676 B. Braun Medical Inc. Introcan Safety 2 IV Catheter 18-24 gauge 04/01/2020
K182870 B. Braun Medical Inc. Introcan Safety 3 Closed IV Catheter 03/07/2019
K970736 B. BRAUN MEDICAL, INC. BRAUN PREFILLED SYRINGE 12/16/1998
K982805 B. BRAUN MEDICAL, INC. INTROCAN SAFETY IV CATHETER 01/14/1999
K020785 B. BRAUN MEDICAL, INC. INTROCAN SAFETY IV CATHETER 08/28/2002
K023253 B. BRAUN MEDICAL, INC. PEDIATRIC CENTRAL VENOUS CATHETER KIT 05/06/2003
K111236 B. BRAUN MELSUNGEN AG INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 08/30/2011
K220756 B.Braun Medical Inc. Introcan Safety 2 IV Catheter 06/23/2022
K213085 B.Braun Medical Inc. Introcan Safety 3 Closed IV Catheter 10/25/2021
K220626 B.Braun Medical Inc. Introcan Safety IV Catheter 05/14/2022
K163358 B.BRAUN MELSUNGEN AG Introcan Safety 3 Closed IV Catheter 04/28/2017
K971991 BARD ACCESS SYSTEMS, INC. GESCO PER-Q-CATH MIDLINE CATHETERS 11/07/1997
K971990 BARD ACCESS SYSTEMS, INC. GESCO PER-Q-CATH PICC CATHETERS 11/07/1997
K190855 Bard Access Systems, Inc. (Bard has joined BD) BD Acute Central Line 11/01/2019
K200266 Bard Access Systems, Inc. (Bard has joined BD) BD Centro Vena Acute Central Line (7 French Dual Lumen) 04/07/2020
K955839 BAXTER EDWARDS MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER 03/25/1996
K984590 BAXTER HEALTHCARE CORP. 0.9% SODIUM CHLORIDE FLUSH SYRINGE 10/07/1999
K003245 BAXTER HEALTHCARE CORP. HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML 12/04/2000
K992532 BAXTER HEALTHCARE CORP. VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING 06/13/2000
K011982 BD 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE 07/17/2001
K011967 BD BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE 01/23/2002
K003553 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE 03/21/2001
K984059 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER 04/09/1999
K982558 BD/PREEFIL BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE 03/08/2000
K033500 BECTON DICKINSON & CO. BD CAREFLOW CENTRAL VENOUS CATHETER 01/29/2004
K110443 BECTON DICKINSON & CO. BD INSYTE AUTOGUARD BC 07/19/2011
K111366 BECTON DICKINSON AND COMPANY (BD) BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM 09/30/2011
K201717 Becton Dickinson Infusion Therapy Systems Inc. BD Cathena Safety IV Catheter 09/22/2020
K220584 Becton Dickinson Infusion Therapy Systems Inc. BD Cathena Safety IV Catheter 03/31/2022
K143610 Becton Dickinson Infusion Therapy Systems Inc. BD INTIMA II CLOSED IV CATHETER 04/09/2015
K183399 Becton Dickinson Infusion Therapy Systems Inc. BD Nexiva Closed IV Catheter System 03/20/2019
K123734 BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM 01/17/2013
K231239 Becton Dickinson Infusion Therapy Systems Inc. NexivaÖ Closed IV Catheter System with NearPortÖ IV Access 09/22/2023
K151698 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD Angiocath IV Catheter, BD Insyte IV Catheter 07/27/2015
K002033 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS 07/26/2000
K100775 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD INTIMA II CLOSED IV CATHETER 06/03/2010
K161777 Becton Dickinson Infusion Therapy Systems, Inc. BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems 08/29/2016
K102520 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD NEXIVA CLOSED IV CATHETER SYSTEM 01/06/2011
K173354 Becton Dickinson Infusion Therapy Systems, Inc. BD Nexiva Diffusics Closed IV Catheter Systems 12/15/2017
K042862 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. BD ONECATH 12/03/2004
K972254 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. FIRST MIDCATH CATHETER 09/12/1997
K972264 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. FIRST MIDCATH CATHETER 09/15/1997
K972262 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. FIRST PICC CATHETER 09/15/1997
K972263 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. FIRST PICC CATHETER WITH DUAL LUMENS 09/15/1997
K000235 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. INSYTE CATHETER, INSYTE AUTOGUARD CATHETER 04/05/2000
K013073 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS 11/08/2001
K013800 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE 12/21/2001
K974764 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. INTROSYTE CATHETER 02/26/1998
K032843 BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NEXIVA CLOSED IV CATHETER SYSTEM 02/27/2004
K964050 BECTON DICKINSON VASCULAR ACCESS, INC. FIRST MIDCATH CATHETER 01/06/1997
K964048 BECTON DICKINSON VASCULAR ACCESS, INC. FIRST MIDCATH CATHETER KIT 01/06/1997
K964049 BECTON DICKINSON VASCULAR ACCESS, INC. FIRST MIDCATH CATHETER WITH DUAL LUMENS 01/06/1997
K971339 BECTON DICKINSON VASCULAR ACCESS, INC. INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS 12/24/1997
K172506 Becton, Dickinson and Company BD Cathena Safety IV Catheter 09/17/2017
K201075 Becton, Dickinson and Company BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter 12/18/2020
K200891 Becton, Dickinson and Company BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System 06/02/2021
K172204 Becton, Dickinson and Company BD Intima II PLUS Closed IV Catheter System 08/17/2017
K170336 Becton, Dickinson and Company BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector 03/10/2017
K170283 Becton, Dickinson and Company BD Nexiva Diffusics Closed IV Catheter System 02/28/2017
K192493 Becton, Dickinson Infusion Therapy Systems, Inc. BD Cathena (TM) Safety IV Catheter 01/24/2020
K032292 BIOTEQUE CORP. BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX 03/22/2004
K980566 BOSTON SCIENTIFIC CORP. VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER 09/14/1998
K191232 C.R. Bard, Inc AccuCath Ace Intravascular Catheter 09/18/2019
K153298 C.R. Bard, Inc. AccuCath Intravascular Catheter 12/10/2015
K121073 C.R. BARD, INC. POWERGLIDE MIDLINE CATHETER 06/01/2012
K133856 C.R. BARD, INC. POWERGLIDE MIDLINE CATHETER 01/16/2014
K153280 C.R. BARD, INC. PowerGlide Pro Midline Catheter 06/02/2016
K162377 C.R. BARD, INC. PowerGlide Pro Midline Catheter 09/22/2016
K060341 C.R. BARD, INC. SHERLOCK TIP LOCATION SYSTEM (TLS) 04/14/2006
K162894 C.R.BARD, INC. AccuCath Intravascular Catheter 11/15/2016
K981368 CATHETER INNOVATIONS, INC. PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS 05/01/1998
K981382 CATHETER INNOVATIONS, INC. PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS 05/01/1998
K223648 Cook Advanced Technologies Cook« Spectrum« 2 MRC Central Venous Catheter 02/03/2023
K182252 Cook Incorporated Cook Unimpregnated Central Venous Catheter 05/17/2019
K100974 COOK INCORPORATED SPECTRUM TURBO-JECT PICC SET 05/06/2010
K950118 COOK, INC. ABRM CATHETER 02/08/1996
K081113 COOK, INC. COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS 07/30/2008
K032274 COOK, INC. COOK FIVE LUMEN CENTRAL VENOUS CATHETER 02/26/2004
K010034 COOK, INC. DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- 01/24/2001
K033843 COOK, INC. SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING 08/12/2004
K060174 COOK, INC. SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM 02/17/2006
K021557 COOK, INC. SPECTRUM SILICONE CATHETER 05/30/2003
K081690 COOK, INC. SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER 07/14/2008
K013182 COOK, INC. TRIPLE LUMEN CENTRAL VENOUS CATHETER 07/01/2002
K992198 COOK, INC. URETHANE PICC LINE MODEL UPICS- 08/27/1999
K974015 DAVIS & GECK, INC. ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL 05/18/1998
K200373 Delta Med Spa Deltaven Fast Flash Closed I.V. Catheter Systems 08/26/2020
K171530 Delta Med SpA Deltaven XiV Max, Deltaven XiV Max FF 12/21/2017
K121007 DELTA MED SRL NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 12/28/2012
K954428 DOUGLAS MEDICAL PRODUCTS CORP. SOLOPICC 24 (60CM) 20GA CATHETER 03/28/1996
K992732 DUMEX MEDICAL SURGICAL PRODUCTS, LTD. STERILE WATER & STERILE 0.9% SODIUM CHLORIDE 04/20/2000
K063469 EASTERN MEDIKIT LTD. MEDICAN ALPHA 12/01/2006
K033250 EDWARDS LIFESCIENCES, LLC. EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR 12/30/2003
K113565 EDWARDS LIFESCIENCES, LLC. MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN 05/18/2012
K091709 EDWARDS LIFESCIENCES, LLC. MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC 10/13/2009
K043446 EMMEBI SRL EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER 02/04/2005
K002142 EMT-RX SALINE IV FLUSH SYRINGE 01/28/2002
K030571 ETHICON ENDO-SURGERY, INC. ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER 03/28/2003
K012128 ETHICON ENDO-SURGERY, INC. PROTECTIV ACUVANCE IV CATHETER SYSTEM 08/01/2001
K962938 EXCELSIOR MEDICAL CORP. EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) 10/25/1996
K053120 EXCELSIOR MEDICAL CORP. STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES 12/09/2005
K080793 FLEXICATH LTD. FIRMGRIP 10/16/2008
K111939 FLEXICATH LTD. M/29TM - PRESSURE INJECTABLE 07/11/2012
K092629 FLEXICATH LTD. SNM FIRMGRIP 09/25/2009
K070451 FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD ABLE CENTRAL VENOUS CATHETER 07/31/2007
K193158 Global Medikit Limited ACENTÖ Central Venous Catheter 11/24/2020
K033853 HDC CORP. MODIFICATION TO V-CATH POLY PICC 01/14/2004
K022099 HDC CORP. SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S 09/20/2002
K964966 HDC CORP. V-CATH 03/05/1997
K983916 HDC CORP. V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) 11/23/1998
K983409 HDC CORP. V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 10/16/1998
K192533 Health Line International Corporation Health Line CT CVC 12/10/2019
K200263 Health Line International Corporation Health Line CT Midline Catheter 03/12/2020
K140270 HEALTH LINE INTERNATIONAL CORPORATION NEXUS MIDLINE CT CATHETER 08/20/2014
K113622 HEALTH LINE INTERNATIONAL CORPORATION (HLIC) ORION II CT CVC 05/18/2012
K142797 Jiangxi Sanxin Medtec Co., Ltd I.V. Catheter 06/18/2015
K010406 JMS CO., LTD. JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G 06/20/2001
K010410 JMS CO., LTD. JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G 06/20/2001
K030479 JMS NORTH AMERICA CORP. JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET 08/18/2003
K121488 JMS NORTH AMERICA CORPORATION JMS SAFE WING CATH (SWC) 03/05/2013
K990236 JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT 08/20/1999
K980493 JOHNSON & JOHNSON MEDICAL, INC. I.V. CATHETER SYSTEM 04/28/1998
K962226 JOHNSON & JOHNSON MEDICAL, INC. PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM 12/23/1996
K011860 KEYSTONE MEDICAL KEYST0NE MEDICAL PICC CATHETER 06/27/2001
K963867 KLEIN-BAKER MEDICAL, INC. NEO-CARE CATHETERIZATION TRAY 11/06/1996
K123267 KOFU FACTORY OF TERUMO CORP. SURFFLASH(R) PLUS SAFETY I.V. CATHETER 11/02/2012
K141138 KOFU FACTORY OF TERUMO CORP. SURFLASH SAFETY I.V. CATHETER 05/30/2014
K954887 LOCKETT MEDICAL CORP. STERILE WATER O.9% STERILE SALINE 01/24/1996
K000997 LUCENT MEDICAL SYSTEMS ZORTRAN DETECTOR 09/07/2000
K974543 LUTHER MEDICAL PRODUCTS, INC. L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER 02/10/1998
K130518 LUTHER NEEDLESAFE PRODUCTS, INC. MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER 04/30/2013
K984189 MAXXIM MEDICAL ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER 05/05/1999
K960013 MDC RESEARCH LTD. MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM 02/13/1996
K953811 MEDCOMP MEDCOMP P-CATH 07/25/1996
K993518 MEDEFIL, INC. MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL 06/12/2000
K993515 MEDEFIL, INC. MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L 02/25/2000
K010021 MEDICAL COMPONENTS, INC. MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S 02/23/2001
K973561 MEDICAL COMPONENTS, INC. MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M 05/11/1998
K040427 MEDICAL DEVICE TECHNOLOGIES, INC. FIBREX CATHETER PATENCY DEVICE 05/03/2004
K192230 MediFirst Co., Ltd. MF SAFECATH 04/23/2020
K210037 Mediplus (India) Limited Pluski Safe 1 Safety IV Catheter 03/25/2022
K041345 MEDIX, INC. PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES 07/22/2004
K150611 MedSource International MedSource ClearSafe Safety IV Catheter 07/15/2015
K223788 MedSource International LLC The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter 09/15/2023
K161779 MedSource International, LLC MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter 11/03/2016
K131555 MEDSOURCE INTERNATIONAL, LLC. MEDSOURCE IV SAFETY CATHETER 01/31/2014
K193278 MedSource Labs MedSource CathMED IV Catheter 08/07/2020
K951620 MENLO CARE, INC. MIDMARK MIDLINE CATHETER 04/04/1996
K182538 Merit Medical Singapore Pte. Ltd. Merit RadialFlo Arterial Catheter 01/16/2019
K953335 MICRO THERAPEUTICS, INC. MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER 01/23/1996
K011937 MICRO THERAPEUTICS, INC. TRULINE INFUSION CATHETERS 08/28/2001
K021139 MICRO THERAPEUTICS, INC. TRULINE REINFORCED VALVED INFUSION CATHETER 04/17/2002
K042504 MYCO MEDICAL SUPPLIES, INC. CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER 01/19/2006
K953252 MYCO MEDICAL SUPPLIES, INC. DISPOSABLE SCALP VEIN INFUSION SET 11/26/1996
K150407 NAVILYST MEDICAL, INC. BioFlo Midline Catheter 05/15/2015
K161866 NAVILYST MEDICAL, INC. BioFlo Midline Catheter 09/08/2016
K032777 NIPRO MEDICAL CORP. MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE 11/14/2003
K022756 NIPRO MEDICAL CORP. NIPRO BIO-FLEX CATHETER 10/18/2002
K013287 NIPRO MEDICAL CORP. NIPRO SAFELET CATH 12/03/2001
K011297 NIPRO MEDICAL CORP. NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET 06/20/2001
K161681 NIPRO MEDICAL CORPORATION Nipro SafeTouch IV Catheter 03/08/2017
K140136 NIPRO MEDICAL CORPORATION NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE 02/14/2014
K132153 NIPRO MEDICAL CORPORATION SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER 12/05/2013
K113429 NIPRO MEDICAL CORPORATION SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER 03/12/2012
K960051 NISSHO CORP. NIPRO SAFELET CATH 03/28/1996
K955053 NISSHO CORP. NIPRO SCALP VEIN SET (DISPOSABL PSV SET) 01/04/1996
K052389 PATTON MEDICAL DEVICES I-PORT 09/09/2005
K062108 PITANGO MEDICAL LTD COMCASET SAFETY IV CATHETER 08/08/2006
K070020 PITANGO MEDICAL LTD COMCASET-P SAFETY IV CATHETER 08/16/2007
K230616 Poly Medicure Limited Polyguard and Polyshield Safety IV Catheters 05/05/2023
K231401 Poly Medicure Limited Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva 09/21/2023
K051355 RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT I.V. CATHETER 09/23/2005
K081420 RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT I.V. CATHETER 11/07/2008
K990390 ROCAP DIV. OF SABRATEK CORP. HEPARIN IV FLUSH SYRINGE, 10 U/ML \ 12/10/1999
K984614 ROCAP DIV. OF SABRATEK CORP. NORMAL SALINE FLUSH SYRINGE 05/27/1999
K990308 ROCAP DIV. OF SABRATEK CORP. ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML 12/10/1999
K221827 Saudi Mais Co. for Medical Products Mais Central Venous Catheter 06/23/2023
K960764 SCIENTIFIC DEVICE MANUFACTURER LLC. SAFE-CATH 04/24/1997
K071382 SHIN CHANG MEDICAL CO., LTD. SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, 10/16/2007
K202060 Shinva Ande Healthcare Apparatus Co., Ltd. Disposable IV catheter 07/23/2021
K984055 SIMS DELTEC, INC. CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS 01/29/1999
K231626 SkyDance Vascular, Inc. OSPREY Closed IV Catheter System (OspreyV2) 08/31/2023
K223018 SkyDance Vascular, Inc. OSPREY PERIPHERAL IV Catheter System 04/14/2023
K072419 SMITHS MEDICAL ASD, INC. ADVANTIV SAFETY I.V. CATHETER 11/09/2007
K160235 SMITHS MEDICAL ASD, INC. ViaValve Safety I.V. Catheter 06/30/2016
K113700 SMITHS MEDICAL ASD, INC. VIAVALVE SAFETY IV CATHETER 03/14/2012
K021130 SPECIAL MEDICAL CO. LTD. SPECATH CENTRAL VENOUS CATHETER KITS 01/07/2003
K024007 SUNDER BIOMEDICAL TECH. CO., LTD. SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J 07/14/2003
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K212370 Vygon USA Leaderflex Mini and Leaderflex Nano 08/29/2022
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