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 |
| K244059 | Access Vascular, Inc. | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | 03/27/2025 |
| 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 |
| K242281 | Arrow International, LLC (A Subsidiary of Teleflex, Inc.) | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral | 12/20/2024 |
| K243599 | Arrow International, LLC (A Subsidiary of Teleflex, Inc.) | ArrowÖ EnduranceÖ Extended Dwell Peripheral Catheter System (EDC-00818) | 03/14/2025 |
| 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 |
| K241845 | B. Braun Medical Inc. | Introcan Safety« 2 IV Catheter | 07/26/2024 |
| 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 |
| K233106 | Bard Access Systems, Inc. (C.R. Bard, Inc.) | AccuCath AceÖ Intravascular Catheter | 04/19/2024 |
| 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 |
| K251155 | Becton Dickinson Infusion Therapy Systems Inc. | BD CathenaÖ Safety IV Catheter | 07/11/2025 |
| K251654 | Becton Dickinson Infusion Therapy Systems Inc. | BD InsyteÖ AutoguardÖ Shielded IV Catheter, BD InsyteÖ AutoguardÖ BC Shielded IV Catheter and BD InsyteÖ AutoguardÖ BC Pro Shielded IV Catheter | 06/27/2025 |
| 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 |
| K243403 | Becton Dickinson Infusion Therapy Systems Inc. | BD NexivaÖ Closed IV Catheter System | 07/25/2025 |
| K250682 | Becton Dickinson Infusion Therapy Systems Inc. | BD NexivaÖ DiffusicsÖ Closed IV Catheter System and BD NexivaÖ DiffusicsÖ Closed IV Catheter System with BD MaxZeroÖ Needle-free Connector | 06/03/2025 |
| K233529 | Becton Dickinson Infusion Therapy Systems Inc. | BD NexivaÖ DiffusicsÖ Closed IV Catheter System with BD MaxZeroÖ Needle-free Connector | 12/01/2023 |
| 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 |
| K240359 | Becton, Dickinson and Company (Bard Access Systems, Inc.) | PowerGlide ProÖ Midline Catheter | 07/29/2024 |
| 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 |
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