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 |
K002786 |
SUNSCOPE INTL., INC. |
BIOSENSORS CENTRAL VENOUS CATHETER KITS |
11/17/2000 |
K160374 |
TANGENT MEDICAL TECHNOLOGIES, INC. |
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System |
03/11/2016 |
K120839 |
TANGENT MEDICAL TECHNOLOGIES, INC. |
NOVACATH SECURE IV CATHETER SYSTEM-18G |
07/20/2012 |
K133280 |
TERUMO (PHILIPPINES) CORPORATION |
TERUMO SURFLO I.V. CATHETER |
06/12/2014 |
K090973 |
TERUMO CORP. |
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) |
05/01/2009 |
K100282 |
TERUMO CORP. |
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER |
02/26/2010 |
K122544 |
TERUMO Corporation |
TERUMO SURFLASH SAFETY I.V. CATHETER |
09/05/2012 |
K082362 |
TERUMO MEDICAL CORP. |
SURSHIELD SAFETY I.V. CATHETER |
09/17/2008 |
K082997 |
TERUMO MEDICAL CORP. |
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER |
04/15/2009 |
K991406 |
TERUMO MEDICAL CORP. |
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER |
06/16/1999 |
K000665 |
TFX MEDICAL, INC. |
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER |
05/02/2000 |
K000087 |
THE KENDAL CO. |
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR |
03/17/2000 |
K190001 |
TOGO MEDIKIT Co., Ltd. |
Supercath 5 |
09/20/2019 |
K081953 |
TOGO MEDIKIT CO., LTD. |
SUPERCATH 5 |
03/12/2009 |
K172496 |
TOGO Medikit Co., Ltd. |
SUPERCATH 5 (26G) |
03/23/2018 |
K093546 |
TOGO MEDIKIT CO., LTD. |
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX |
12/17/2009 |
K160592 |
TOGO MEDIKIT CO., LTD. |
SUPERCATH 6 |
08/12/2016 |
K050114 |
TOGO MEDIKIT CO., LTD. |
SUPERCATH Z3V |
06/09/2005 |
K112290 |
TOGO MEDIKIT CO., LTD. |
SUPERCATH Z3V |
04/16/2012 |
K140419 |
TOGO MEDIKIT CO., LTD. |
SUPERCATH5 |
05/12/2014 |
K013556 |
TYCO HEALTHCARE |
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE |
12/31/2001 |
K090502 |
U.S. SAFETY SYRINGES CO., INC. |
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET |
03/10/2009 |
K083454 |
U.S. SAFETY SYRINGES CO., INC. |
NUOVOCATH |
12/04/2008 |
K090122 |
U.S. SAFETY SYRINGES CO., INC. |
NUOVOGUARD |
02/05/2009 |
K120337 |
UNOMEDICAL A/S |
I-PORT ADVANCE INJECTION PORT |
02/16/2012 |
K073241 |
VASCULAR PATHWAYS |
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM |
02/08/2008 |
K140504 |
VASCULAR PATHWAYS, INC. |
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM |
07/17/2014 |
K142136 |
VASCULAR PATHWAYS, INC. |
ACCUCATH MIDLINE CATHETER SYSTEM |
01/08/2015 |
K112347 |
VASCULAR PATHWAYS, INC. |
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE |
09/22/2011 |
K141026 |
VYGON |
LEADERFLEX |
07/30/2014 |
K070705 |
VYGON CORP. |
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 |
11/30/2007 |
K061250 |
VYGON CORP. |
MULTICATH EXPERT |
09/29/2006 |
K052881 |
VYGON CORP. |
VYGON LATEX FREE BIONECTOR |
03/02/2006 |
K052564 |
VYGON CORP. |
VYGON LEADER-FLEX |
04/05/2006 |
K954112 |
VYGON CORP. |
VYGON LIFEVAC MID-LINE TRAY |
05/09/1996 |
K963196 |
VYGON CORP. |
VYGON UMBILICAL CATHETHER INSERTION TRAY |
09/09/1997 |
K212370 |
Vygon USA |
Leaderflex Mini and Leaderflex Nano |
08/29/2022 |
K083429 |
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. |
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT |
08/07/2009 |
K210929 |
Woo Young Medical Co., Ltd. |
MagiCath II |
09/13/2022 |
K112542 |
YOMURA TECHNOLOGIES INC. |
YOMURA SAFETY I.V. CATHETER |
02/08/2012 |