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 3 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K011297 | NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET | Nipro Medical Corp. | 2001-06-20 | Traditional | PDF ↗ |
| K003187 | VACUCATH I.V. CATHETER INTRODUCTER | Auto/Cath Vascular Access, Inc. | 2001-05-21 | Traditional | PDF ↗ |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-03-21 | Traditional | PDF ↗ |
| K010021 | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S | Medical Components, Inc. | 2001-02-23 | Traditional | PDF ↗ |
| K010034 | DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- | Cook, Inc. | 2001-01-24 | Special | PDF ↗ |
| K003245 | HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML | Baxter Healthcare Corp | 2000-12-04 | Special | PDF ↗ |
| K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | Sunscope Intl., Inc. | 2000-11-17 | Traditional | PDF ↗ |
| K000632 | 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE | Avitro, LLC | 2000-10-19 | Traditional | PDF ↗ |
| K001795 | THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD | Avitro, LLC | 2000-10-19 | Traditional | PDF ↗ |
| K000997 | ZORTRAN DETECTOR | Lucent Medical Systems | 2000-09-07 | Traditional | PDF ↗ |
| K001616 | MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE | Abbott Laboratories | 2000-07-27 | Special | PDF ↗ |
| K002033 | BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS | Becton Dickinson Infusion Therapy Systems, Inc. | 2000-07-26 | Special | PDF ↗ |
| K992532 | VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING | Baxter Healthcare Corp | 2000-06-13 | Traditional | PDF ↗ |
| K993518 | 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 | Medefil, Inc. | 2000-06-12 | Traditional | PDF ↗ |
| K000665 | TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER | Tfx Medical, Inc. | 2000-05-02 | Abbreviated | PDF ↗ |
| K992732 | STERILE WATER & STERILE 0.9% SODIUM CHLORIDE | Dumex Medical Surgical Products, Ltd. | 2000-04-20 | Traditional | PDF ↗ |
| K000235 | INSYTE CATHETER, INSYTE AUTOGUARD CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 2000-04-05 | Traditional | PDF ↗ |
| K000087 | MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR | The Kendal Co. | 2000-03-17 | Traditional | PDF ↗ |
| K982558 | BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE | Bd/Preefil | 2000-03-08 | Traditional | PDF ↗ |
| K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER | Arrow Intl., Inc. | 2000-03-08 | Traditional | PDF ↗ |
| K993515 | 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 | Medefil, Inc. | 2000-02-25 | Traditional | PDF ↗ |
| K990308 | ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML | Rocap Div. of Sabratek Corp. | 1999-12-10 | Traditional | PDF ↗ |
| K990390 | HEPARIN IV FLUSH SYRINGE, 10 U/ML \ | Rocap Div. of Sabratek Corp. | 1999-12-10 | Traditional | PDF ↗ |
| K984590 | 0.9% SODIUM CHLORIDE FLUSH SYRINGE | Baxter Healthcare Corp | 1999-10-07 | Traditional | PDF ↗ |
| K992198 | URETHANE PICC LINE MODEL UPICS- | Cook, Inc. | 1999-08-27 | Special | PDF ↗ |
| K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1999-08-20 | Traditional | PDF ↗ |
| K991406 | TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER | Terumo Medical Corp. | 1999-06-16 | Traditional | PDF ↗ |
| K984614 | NORMAL SALINE FLUSH SYRINGE | Rocap Div. of Sabratek Corp. | 1999-05-27 | Traditional | PDF ↗ |
| K984189 | ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER | Maxxim Medical | 1999-05-05 | Traditional | PDF ↗ |
| K984059 | ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999-04-09 | Traditional | PDF ↗ |
| K984055 | CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS | Sims Deltec, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K982805 | INTROCAN SAFETY IV CATHETER | B.Braun Medical, Inc. | 1999-01-14 | Traditional | PDF ↗ |
| K970736 | BRAUN PREFILLED SYRINGE | B.Braun Medical, Inc. | 1998-12-16 | Traditional | PDF ↗ |
| K983916 | V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) | Hdc Corp. | 1998-11-23 | Special | PDF ↗ |
| K983409 | V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 | Hdc Corp. | 1998-10-16 | Special | PDF ↗ |
| K980566 | VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER | Boston Scientific Corp | 1998-09-14 | Traditional | PDF ↗ |
| K981905 | STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 | Acu-Pak | 1998-08-18 | Traditional | PDF ↗ |
| K974015 | ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL | Davis & Geck, Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K973561 | MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M | Medical Components, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K981382 | PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS | Catheter Innovations, Inc. | 1998-05-01 | Special | PDF ↗ |
| K981368 | PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS | Catheter Innovations, Inc. | 1998-05-01 | Special | PDF ↗ |
| K980493 | I.V. CATHETER SYSTEM | Johnson & Johnson Medical, Inc. | 1998-04-28 | Traditional | PDF ↗ |
| K974764 | INTROSYTE CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1998-02-26 | Traditional | PDF ↗ |
| K974543 | L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER | Luther Medical Products, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K971339 | INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS | Becton Dickinson Vascular Access, Inc. | 1997-12-24 | Traditional | PDF ↗ |
| K971990 | GESCO PER-Q-CATH PICC CATHETERS | Bard Access Systems, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K971991 | GESCO PER-Q-CATH MIDLINE CATHETERS | Bard Access Systems, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K970864 | ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS | Arrow Intl., Inc. | 1997-10-17 | Traditional | PDF ↗ |
| K972264 | FIRST MIDCATH CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 | Traditional | PDF ↗ |
| K972262 | FIRST PICC CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 | Traditional | PDF ↗ |
| K972263 | FIRST PICC CATHETER WITH DUAL LUMENS | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 | Traditional | PDF ↗ |
| K972254 | FIRST MIDCATH CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | Vygon Corp. | 1997-09-09 | Traditional | PDF ↗ |
| K962577 | ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER | Arrow Intl., Inc. | 1997-08-21 | Traditional | PDF ↗ |
| K970669 | AEROQUIP SAFESTART IV CATHETER | Aeroquip Medical Products | 1997-08-01 | Traditional | PDF ↗ |
| K970644 | AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM | Aeroquip Medical Products | 1997-07-31 | Traditional | PDF ↗ |
| K960764 | SAFE-CATH | Scientific Device Manufacturer, LLC | 1997-04-24 | Traditional | PDF ↗ |
| K964966 | V-CATH | Hdc Corp. | 1997-03-05 | Traditional | PDF ↗ |
| K961552 | CVP POLYURETHANE CATHETER | Abbott Laboratories | 1997-02-10 | Traditional | PDF ↗ |
| K964049 | FIRST MIDCATH CATHETER WITH DUAL LUMENS | Becton Dickinson Vascular Access, Inc. | 1997-01-06 | Traditional | PDF ↗ |
| K964048 | FIRST MIDCATH CATHETER KIT | Becton Dickinson Vascular Access, Inc. | 1997-01-06 | Traditional | PDF ↗ |
| K964050 | FIRST MIDCATH CATHETER | Becton Dickinson Vascular Access, Inc. | 1997-01-06 | Traditional | PDF ↗ |
| K962226 | PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM | Johnson & Johnson Medical, Inc. | 1996-12-23 | Traditional | PDF ↗ |
| K953252 | DISPOSABLE SCALP VEIN INFUSION SET | Myco Medical Supplies, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963867 | NEO-CARE CATHETERIZATION TRAY | Klein-Baker Medical, Inc. | 1996-11-06 | Traditional | PDF ↗ |
| K962938 | EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) | Excelsior Medical Corp. | 1996-10-25 | Traditional | PDF ↗ |
| K953811 | MEDCOMP P-CATH | Medcomp | 1996-07-25 | Traditional | PDF ↗ |
| K953805 | 0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE | Abbott Laboratories | 1996-06-28 | Traditional | PDF ↗ |
| K954112 | VYGON LIFEVAC MID-LINE TRAY | Vygon Corp. | 1996-05-09 | Traditional | PDF ↗ |
| K951620 | MIDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1996-04-04 | Traditional | PDF ↗ |
| K960051 | NIPRO SAFELET CATH | Nissho Corp. | 1996-03-28 | Traditional | PDF ↗ |
| K954428 | SOLOPICC 24 (60CM) 20GA CATHETER | Douglas Medical Products Corp. | 1996-03-28 | Traditional | PDF ↗ |
| K955839 | MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER | Baxter Edwards | 1996-03-25 | Traditional | PDF ↗ |
| K960013 | MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM | MDC Research , Ltd. | 1996-02-13 | Traditional | PDF ↗ |
| K950118 | ABRM CATHETER | Cook, Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K954887 | STERILE WATER O.9% STERILE SALINE | Lockett Medical Corp. | 1996-01-24 | Traditional | PDF ↗ |
| K953335 | MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER | Micro Therapeutics, Inc. | 1996-01-23 | Traditional | PDF ↗ |
| K955053 | NIPRO SCALP VEIN SET (DISPOSABL PSV SET) | Nissho Corp. | 1996-01-04 | Traditional | PDF ↗ |
| K952645 | VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE | Vital Signs, Inc. | 1995-12-13 | Traditional | PDF ↗ |
| K953120 | VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE | Vital Signs, Inc. | 1995-12-13 | Traditional | PDF ↗ |
| K946170 | COMFORT-Q SUBCUTANEOUS INJECTION SETS | B. Braun of America, Inc. | 1995-11-03 | Traditional | PDF ↗ |
| K952058 | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE | Trinity Laboratories, Inc. | 1995-09-21 | Traditional | PDF ↗ |
| K932946 | WALLACE IV CANNULA | Smiths Industries Medical Systems, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K932947 | WALLACE Y-CAN | Smiths Industries Medical Systems, Inc. | 1995-09-01 | Traditional | PDF ↗ |
| K952757 | ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K952861 | ANGIOCATH & INSYTE AUTOGUARD CATHETERS | Becton Dickinson Vascular Access, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K952256 | PICC LINE KIT | Medi-Flex Hospital Products, Inc. | 1995-07-31 | Traditional | PDF ↗ |
| K941678 | BIONECTOR | Vygon Corp. | 1995-06-26 | Traditional | PDF ↗ |
| K950284 | SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR | Sims Deltec, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K945053 | LF CT HIG PRESSURE CATHETERS | Mallinckrodt Group, Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K950301 | ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS | Becton Dickinson Vascular Access, Inc. | 1995-04-18 | Traditional | PDF ↗ |
| K944302 | THE FLEX-SET SUBCUTANEOUS INFUSION SET | Cathco, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY | Menlo Care, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K944336 | CATCO UMBILICAL VESSEL CATHETER | Catco Medical, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K944410 | CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER | Catco Medical, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K944367 | CATCO POLYURETHANE UMBILICAL VESSEL CATHETER | Catco Medical, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K944368 | CATCO SILICONE UMBILICAL VESSEL CATHETER | Catco Medical, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K944504 | CATCO FIRST PICC | Catco Medical, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K944968 | LANDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1995-03-29 | Traditional | PDF ↗ |
| K950737 | LANDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1995-03-29 | Traditional | PDF ↗ |
Product code FOZ · Class II · General Hospital. Data: openFDA.