FDA Product Code
FDA Product Code FOZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5200
510(k) Clearances — 508 records · page 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133856 | POWERGLIDE MIDLINE CATHETER | C.R. Bard, Inc. | 2014-01-16 | Special | PDF ↗ |
| K132153 | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER | Nipro Medical Corporation | 2013-12-05 | Traditional | PDF ↗ |
| K130518 | MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER | Luther Needlesafe Products, Inc. | 2013-04-30 | Traditional | PDF ↗ |
| K121488 | JMS SAFE WING CATH (SWC) | JMS North America Corporation | 2013-03-05 | Traditional | PDF ↗ |
| K123734 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM | Becton Dickinson Infusion Therapy Systems, Inc. | 2013-01-17 | Traditional | PDF ↗ |
| K121007 | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 | Delta Med Srl | 2012-12-28 | Traditional | PDF ↗ |
| K123267 | SURFFLASH(R) PLUS SAFETY I.V. CATHETER | Kofu Factory of Terumo Corp. | 2012-11-02 | Traditional | PDF ↗ |
| K122544 | TERUMO SURFLASH SAFETY I.V. CATHETER | Terumo Corporation | 2012-09-05 | Traditional | PDF ↗ |
| K120839 | NOVACATH SECURE IV CATHETER SYSTEM-18G | Tangent Medical Technologies, Inc. | 2012-07-20 | Traditional | PDF ↗ |
| K111939 | M/29TM - PRESSURE INJECTABLE | Flexicath , Ltd. | 2012-07-11 | Traditional | PDF ↗ |
| K121073 | POWERGLIDE MIDLINE CATHETER | C.R. Bard, Inc. | 2012-06-01 | Traditional | PDF ↗ |
| K113622 | ORION II CT CVC | Health Line International Corporation (Hlic) | 2012-05-18 | Traditional | PDF ↗ |
| K113565 | MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN | Edwards Lifesciences, LLC | 2012-05-18 | Special | PDF ↗ |
| K112290 | SUPERCATH Z3V | Togo Medikit Co., Ltd. | 2012-04-16 | Traditional | PDF ↗ |
| K113700 | VIAVALVE SAFETY IV CATHETER | Smiths Medical Asd, Inc. | 2012-03-14 | Traditional | PDF ↗ |
| K113429 | SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER | Nipro Medical Corporation | 2012-03-12 | Special | PDF ↗ |
| K120337 | I-PORT ADVANCE INJECTION PORT | Unomedical A/S | 2012-02-16 | Abbreviated | PDF ↗ |
| K112542 | YOMURA SAFETY I.V. CATHETER | Yomura Technologies, Inc. | 2012-02-08 | Traditional | PDF ↗ |
| K110794 | AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS | Ameco Medical Industries | 2011-12-21 | Traditional | PDF ↗ |
| K111366 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM | Becton, Dickinson and Company (BD) | 2011-09-30 | Traditional | PDF ↗ |
| K112347 | RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE | Vascular Pathways, Inc. | 2011-09-22 | Special | PDF ↗ |
| K111236 | 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 | B.Braun Melsungen AG | 2011-08-30 | Traditional | PDF ↗ |
| K110443 | BD INSYTE AUTOGUARD BC | Becton, Dickinson & CO | 2011-07-19 | Traditional | PDF ↗ |
| K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | Becton Dickinson Infusion Therapy Systems, Inc. | 2011-01-06 | Special | PDF ↗ |
| K100775 | BD INTIMA II CLOSED IV CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 2010-06-03 | Traditional | PDF ↗ |
| K100974 | SPECTRUM TURBO-JECT PICC SET | Cook Incorporated | 2010-05-06 | Special | PDF ↗ |
| K100282 | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER | Terumo Corp. | 2010-02-26 | Special | PDF ↗ |
| K093546 | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009-12-17 | Special | PDF ↗ |
| K091709 | MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC | Edwards Lifesciences, LLC | 2009-10-13 | Traditional | PDF ↗ |
| K092629 | SNM FIRMGRIP | Flexicath , Ltd. | 2009-09-25 | Special | PDF ↗ |
| K083429 | I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT | Weihai Jierui Medical Products Co., Ltd. | 2009-08-07 | Traditional | PDF ↗ |
| K090973 | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) | Terumo Corp. | 2009-05-01 | Special | PDF ↗ |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Terumo Medical Corp. | 2009-04-15 | Traditional | PDF ↗ |
| K081953 | SUPERCATH 5 | Togo Medikit Co., Ltd. | 2009-03-12 | Traditional | PDF ↗ |
| K090502 | NOVA SAFE SCALP VEIN BLOOD COLLECTION SET | U.S. Safety Syringes Co., Inc. | 2009-03-10 | Traditional | PDF ↗ |
| K090122 | NUOVOGUARD | U.S. Safety Syringes Co., Inc. | 2009-02-05 | Traditional | PDF ↗ |
| K083454 | NUOVOCATH | U.S. Safety Syringes Co., Inc. | 2008-12-04 | Traditional | PDF ↗ |
| K081420 | VANISHPOINT I.V. CATHETER | Retractable Technologies, Inc. | 2008-11-07 | Abbreviated | PDF ↗ |
| K080793 | FIRMGRIP | Flexicath , Ltd. | 2008-10-16 | Traditional | PDF ↗ |
| K082362 | SURSHIELD SAFETY I.V. CATHETER | Terumo Medical Corp. | 2008-09-17 | Traditional | PDF ↗ |
| K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS | Cook, Inc. | 2008-07-30 | Traditional | PDF ↗ |
| K081690 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | Cook, Inc. | 2008-07-14 | Special | PDF ↗ |
| K073471 | VANTAGECATH INTRAVASCULAR CATHETER | Advantage Medical Device | 2008-04-30 | Traditional | PDF ↗ |
| K073520 | ANGIOTECH CVC | Angiotech Pharmaceuticals, Inc. | 2008-04-11 | Traditional | PDF ↗ |
| K073241 | VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM | Vascular Pathways | 2008-02-08 | Abbreviated | PDF ↗ |
| K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | Vygon Corp. | 2007-11-30 | Traditional | PDF ↗ |
| K072419 | ADVANTIV SAFETY I.V. CATHETER | Smiths Medical Asd, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K071382 | 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, | Shinchang Medical Co., Ltd. | 2007-10-16 | Traditional | PDF ↗ |
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | Arrow International, Inc. | 2007-08-30 | Traditional | PDF ↗ |
| K070020 | COMCASET-P SAFETY IV CATHETER | Pitango Medical, Ltd. | 2007-08-16 | Traditional | PDF ↗ |
| K070451 | ABLE CENTRAL VENOUS CATHETER | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2007-07-31 | Traditional | PDF ↗ |
| K063469 | MEDICAN ALPHA | Eastern Medikit , Ltd. | 2006-12-01 | Traditional | PDF ↗ |
| K061250 | MULTICATH EXPERT | Vygon Corp. | 2006-09-29 | Traditional | PDF ↗ |
| K062108 | COMCASET SAFETY IV CATHETER | Pitango Medical, Ltd. | 2006-08-08 | Traditional | PDF ↗ |
| K060341 | SHERLOCK TIP LOCATION SYSTEM (TLS) | C.R. Bard, Inc. | 2006-04-14 | Traditional | PDF ↗ |
| K052564 | VYGON LEADER-FLEX | Vygon Corp. | 2006-04-05 | Traditional | PDF ↗ |
| K052881 | VYGON LATEX FREE BIONECTOR | Vygon Corp. | 2006-03-02 | Traditional | PDF ↗ |
| K060174 | SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM | Cook, Inc. | 2006-02-17 | Special | PDF ↗ |
| K042504 | CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER | Myco Medical Supplies, Inc. | 2006-01-19 | Traditional | PDF ↗ |
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES | Excelsior Medical Corp. | 2005-12-09 | Special | PDF ↗ |
| K051355 | VANISHPOINT I.V. CATHETER | Retractable Technologies, Inc. | 2005-09-23 | Traditional | PDF ↗ |
| K052389 | I-PORT | Patton Medical Devices | 2005-09-09 | Abbreviated | PDF ↗ |
| K050114 | SUPERCATH Z3V | Togo Medikit Co., Ltd. | 2005-06-09 | Traditional | PDF ↗ |
| K043446 | EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER | Emmebi Srl | 2005-02-04 | Traditional | PDF ↗ |
| K042862 | BD ONECATH | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-12-03 | Traditional | PDF ↗ |
| K033843 | SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING | Cook, Inc. | 2004-08-12 | Traditional | PDF ↗ |
| K041345 | PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES | Medix, Inc. | 2004-07-22 | Traditional | PDF ↗ |
| K040427 | FIBREX CATHETER PATENCY DEVICE | Medical Device Technologies, Inc. | 2004-05-03 | Traditional | PDF ↗ |
| K032292 | BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX | Bioteque Corp. | 2004-03-22 | Traditional | PDF ↗ |
| K032843 | NEXIVA CLOSED IV CATHETER SYSTEM | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-02-27 | Traditional | PDF ↗ |
| K032274 | COOK FIVE LUMEN CENTRAL VENOUS CATHETER | Cook, Inc. | 2004-02-26 | Traditional | PDF ↗ |
| K033500 | BD CAREFLOW CENTRAL VENOUS CATHETER | Becton, Dickinson & CO | 2004-01-29 | Traditional | PDF ↗ |
| K033853 | MODIFICATION TO V-CATH POLY PICC | Hdc Corp. | 2004-01-14 | Special | PDF ↗ |
| K033250 | EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR | Edwards Lifesciences, LLC | 2003-12-30 | Traditional | PDF ↗ |
| K032417 | HEPARIN LOCK FLUSH SYRINGE | Am2 Pat, Inc. | 2003-12-23 | Traditional | PDF ↗ |
| K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2003-11-14 | Special | PDF ↗ |
| K032962 | AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE | Arrow Intl., Inc. | 2003-10-29 | Special | PDF ↗ |
| K030479 | JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET | Jms North America Corp. | 2003-08-18 | Traditional | PDF ↗ |
| K024007 | SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J | Sunder Biomedical Tech. Co., Ltd. | 2003-07-14 | Traditional | PDF ↗ |
| K021557 | SPECTRUM SILICONE CATHETER | Cook, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K023253 | PEDIATRIC CENTRAL VENOUS CATHETER KIT | B.Braun Medical, Inc. | 2003-05-06 | Traditional | PDF ↗ |
| K030571 | ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER | Ethicon Endo-Surgery, Inc. | 2003-03-28 | Traditional | PDF ↗ |
| K021130 | SPECATH CENTRAL VENOUS CATHETER KITS | Special Medical Co. , Ltd. | 2003-01-07 | Traditional | PDF ↗ |
| K022756 | NIPRO BIO-FLEX CATHETER | Nipro Medical Corp. | 2002-10-18 | Traditional | PDF ↗ |
| K022099 | SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S | Hdc Corp. | 2002-09-20 | Traditional | PDF ↗ |
| K020785 | INTROCAN SAFETY IV CATHETER | B.Braun Medical, Inc. | 2002-08-28 | Traditional | PDF ↗ |
| K013182 | TRIPLE LUMEN CENTRAL VENOUS CATHETER | Cook, Inc. | 2002-07-01 | Traditional | PDF ↗ |
| K021139 | TRULINE REINFORCED VALVED INFUSION CATHETER | Micro Therapeutics, Inc. | 2002-04-17 | Special | PDF ↗ |
| K002142 | SALINE IV FLUSH SYRINGE | Emt-Rx | 2002-01-28 | Traditional | PDF ↗ |
| K011967 | BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE | Bd | 2002-01-23 | Traditional | PDF ↗ |
| K013556 | MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE | Tyco Healthcare | 2001-12-31 | Traditional | PDF ↗ |
| K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | Becton Dickinson Infusion Therapy Systems, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K013287 | NIPRO SAFELET CATH | Nipro Medical Corp. | 2001-12-03 | Traditional | PDF ↗ |
| K013073 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS | Becton Dickinson Infusion Therapy Systems, Inc. | 2001-11-08 | Traditional | PDF ↗ |
| K011937 | TRULINE INFUSION CATHETERS | Micro Therapeutics, Inc. | 2001-08-28 | Special | PDF ↗ |
| K012128 | PROTECTIV ACUVANCE IV CATHETER SYSTEM | Ethicon Endo-Surgery, Inc. | 2001-08-01 | Traditional | PDF ↗ |
| K011982 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Bd | 2001-07-17 | Special | PDF ↗ |
| K011860 | KEYST0NE MEDICAL PICC CATHETER | Keystone Medical | 2001-06-27 | Traditional | PDF ↗ |
| K010410 | JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G | Jms Co., Ltd. | 2001-06-20 | Traditional | PDF ↗ |
| K010406 | JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G | Jms Co., Ltd. | 2001-06-20 | Traditional | PDF ↗ |
Product code FOZ · Class II · General Hospital. Data: openFDA.