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 4 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K943349 | MAHURKAR DUAL LUMEN CATHETER | Quinton, Inc. | 1995-03-22 | Traditional | PDF ↗ |
| K944660 | ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY | Neostar Medical Technologies, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K944511 | ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC) | Neostar Medical Technologies, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K942045 | INSYTE INTRODUCER CATHETER | Becton Dickinson Vascular Access, Inc. | 1995-01-09 | Traditional | PDF ↗ |
| K933467 | PRN ADAPTER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-12-12 | Traditional | PDF ↗ |
| K935090 | CUFF-CATH | Ohmeda Medical | 1994-10-14 | Traditional | PDF ↗ |
| K940634 | MICRO THERAPEUTICS INFUSION CATHETER | Micro Therapeutics, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K941417 | VITAFLON PLUS/VASCULON | Hogan & Hartson | 1994-10-06 | Traditional | PDF ↗ |
| K943023 | CVD BULLETT PERIPHERAL INFUSION CATHETER | Cardiovascular Dynamics, Inc. | 1994-09-30 | Traditional | PDF ↗ |
| K932789 | ONE-SITE IV CONNECTOR | Care Medical Devices, Inc. | 1994-07-28 | Traditional | PDF ↗ |
| K940775 | INJECTION CAP | Medron, Inc. | 1994-06-15 | Traditional | PDF ↗ |
| K940441 | DIAL MEDICAL SUPPLY FISTULA NEEDLE SET | Dial Medical of Florida, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K940385 | NAVIGATOR-MP CATHETER LOCATION INSTRUMENT | Navion Biomedical Corp. | 1994-06-02 | Traditional | PDF ↗ |
| K930048 | SAFE-PICC CATHETER | Menlo Care, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K931073 | CATH-FINDER | Pharmacia Deltec, Inc. | 1994-05-05 | Traditional | PDF ↗ |
| K926544 | PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH | Pharmacia Deltec, Inc. | 1994-03-21 | Traditional | PDF ↗ |
| K931668 | PICC INSERTION TRAY | Clinipad Corp. | 1994-03-07 | Traditional | PDF ↗ |
| K931729 | I.V. START KIT | Carapace, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K932071 | I.V. START KIT | Clinipad Corp. | 1994-02-17 | Traditional | PDF ↗ |
| K931027 | BULLETT PERIPHERAL INFUSION CATHETER | Cardio-Dynamics, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K926405 | .9% NORMAL SALINE TUBE/STERILE WATER TUBE | Gam-Med Packaging Corp. | 1994-02-03 | Traditional | PDF ↗ |
| K933050 | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH | Critikon Company, LLC | 1993-12-14 | Traditional | PDF ↗ |
| K923702 | INTIMA POINT GUARD INTRAVASCULAR CATHETER | Becton Dickinson Vascular Access, Inc. | 1993-09-22 | Traditional | PDF ↗ |
| K926097 | CYBILNATE(R) UMBILICAL CATHETER | Cyex Medical Technologies, Inc. | 1993-08-31 | Traditional | PDF ↗ |
| K923323 | INTERMITTENT INJECTION SITE | Kawasumi Laboratories Co., Ltd. | 1993-07-13 | Traditional | PDF ↗ |
| K924968 | L-CATH PEEL-AWAY CATHETER SYSTEM | Luther Medical Products, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K914378 | PERIPHERAL INTERVENOUS CATHETER | Medical Profiles, Inc. | 1993-05-20 | Traditional | PDF ↗ |
| K920638 | BIO-MATE PIC CATHETER | Medevice, Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K915824 | HOLE PUNCH | American Biomaterials Corp. | 1993-01-29 | Traditional | PDF ↗ |
| K921955 | QUIK FLOW | California Medical Equipment, Inc. | 1993-01-29 | Traditional | PDF ↗ |
| K914528 | SAFEDWEL(R) CENTRAL VENOUS CATHETER | Becton Dickinson Vascular Access, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K921270 | SAFE-DWELL PLUS CENTRAL VENOUS CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-09-28 | Traditional | PDF ↗ |
| K920828 | SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT | Menlo Care, Inc. | 1992-08-14 | Traditional | PDF ↗ |
| K914180 | DESERET(R) FLOW RESTRICTION VALVE | Becton Dickinson Vascular Access, Inc. | 1992-05-08 | Traditional | PDF ↗ |
| K920635 | E-Z SET/MINICATH INFUSION SETS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-06 | Traditional | PDF ↗ |
| K920128 | VERSACATH MAINLINE CENTRAL VENOUS CATHETER | Menlo Care, Inc. | 1992-03-26 | Traditional | PDF ↗ |
| K920133 | VERSACATH SELECTALUMEN INNER CATHETER | Menlo Care, Inc. | 1992-03-26 | Traditional | PDF ↗ |
| K920028 | LANDMARK MIDLINE CATHETER | Menlo Care, Inc. | 1992-03-26 | Traditional | PDF ↗ |
| K915065 | I.V.IRRIGATION POLE | American Medical Mfg., Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K912358 | LANDMARK ADD-A-LUMEN CATHETER KIT | Menlo Care, Inc. | 1992-01-02 | Traditional | PDF ↗ |
| K912165 | LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM | Menlo Care, Inc. | 1991-12-11 | Traditional | PDF ↗ |
| K911251 | FLEX-IV | Medway | 1991-10-28 | Traditional | PDF ↗ |
| K912158 | CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY | Medical Device Inspection Co., Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K912563 | ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE | Mbo Laboratories, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K905415 | BRAIDED HIGH PRESSURE CATHETER CONNECTOR | The R Group | 1991-08-12 | Traditional | PDF ↗ |
| K910566 | VERSACATH(TM) MULTILUMEN SYSTEM | Menlo Care, Inc. | 1991-06-03 | Traditional | PDF ↗ |
| K910565 | VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY | Menlo Care, Inc. | 1991-06-03 | Traditional | PDF ↗ |
| K910564 | VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY | Menlo Care, Inc. | 1991-05-06 | Traditional | PDF ↗ |
| K910572 | INJECTION CAPS | Akcess Medical Products, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K910799 | LANDMARK VENOUS ACCESS DEVICE | Menlo Care, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K904558 | DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL | Davol, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K905463 | GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION | Angiosystems, Inc. | 1991-01-22 | Traditional | PDF ↗ |
| K905009 | DIGITCARE I.V. START KIT | Digitcare Corp. | 1990-12-18 | Traditional | PDF ↗ |
| K904648 | SAFE SYTE I.V. CATHETER PLACEMENT UNIT | Deseret Medical, Inc. | 1990-12-14 | Traditional | PDF ↗ |
| K903347 | SODIUM CHLORIDE SOLUTION | Superior Healthcare Group, Inc. | 1990-12-13 | Traditional | PDF ↗ |
| K904150 | CATH-FINDER(TM) CATHETER TRACKING SYSTEM | Pharmacia Deltec, Inc. | 1990-11-19 | Traditional | PDF ↗ |
| K903545 | CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS | J.J. Skinner, Inc. | 1990-11-13 | Traditional | PDF ↗ |
| K904121 | VIALON OBTURATOR | Deseret Medical, Inc. | 1990-11-08 | Traditional | PDF ↗ |
| K896813 | MODIFIED INTRAVENOUS CATHETER | Safeguard Needle Co. | 1990-10-19 | Traditional | PDF ↗ |
| K904122 | INSYTE-A ARTERIAL CATHETERIZATION UNIT | Deseret Medical, Inc. | 1990-10-04 | Traditional | PDF ↗ |
| K903732 | KENDALL SAFETRAK(TM) HIGH FLOW CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1990-10-03 | Traditional | PDF ↗ |
| K901701 | CENTRAL VENOUS ACCESS CATHETER | Cardiopulmonics, Inc. | 1990-09-19 | Traditional | PDF ↗ |
| K902527 | SPLIT-SECOND INTRODUCER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-09-12 | Traditional | PDF ↗ |
| K895597 | VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER | Vas-Cath, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K895812 | SHARGHP INTRAVENOUS CATHETER | Shargh Pharmaceutical Co., Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K901263 | NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM | Navion Biomedical Corp. | 1990-08-22 | Traditional | PDF ↗ |
| K900056 | CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE | Abbott Laboratories | 1990-08-15 | Traditional | PDF ↗ |
| K901640 | MULTICATH PLACEMENT KIT | Vygon Corp. | 1990-08-10 | Traditional | PDF ↗ |
| K902135 | PERCUTANEOUS INTRODUCER KIT | Device Labs, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K900263 | ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER | Arrow Intl., Inc. | 1990-07-24 | Traditional | PDF ↗ |
| K895942 | GESCO DUAL LUMEN PER-Q-CATH-DL | Gesco Intl., Inc. | 1990-07-02 | Traditional | PDF ↗ |
| K900116 | DESERET OPTIMA INTRAVASCULAR CATHETER | Deseret Medical, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K895734 | DESERET INTRAVASCULAR CATHETER | Deseret Medical, Inc. | 1990-04-09 | Traditional | PDF ↗ |
| K895768 | EXEL SAFELET CATHETER | Exel Intl. | 1990-02-16 | Traditional | PDF ↗ |
| K896774 | STREAMLINE VASCULAR ACCESS DEVICE | Menlo Care, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K894611 | CATHETER CARE KITS | L H M Ent., Inc. | 1989-12-15 | Traditional | PDF ↗ |
| K895191 | ANTI-THROMBOGENIC COATING FOR CATHETERS | Burron Medical, Inc. | 1989-11-24 | Traditional | PDF ↗ |
| K893546 | OPTICALLY CLEAR RADIOPAQUE CATHETER | Critikon Company, LLC | 1989-11-01 | Traditional | PDF ↗ |
| K894371 | NIPRO SAFELET CATH | Pharma-Plast USA, Inc. | 1989-10-25 | Traditional | PDF ↗ |
| K893965 | PROLONG INTRAVASCULAR CATHETER | Baxter Healthcare Corp | 1989-09-08 | Traditional | PDF ↗ |
| K884577 | PROCEDURE READY TRAYS | Professional Medical Services | 1989-08-01 | Traditional | PDF ↗ |
| K893003 | TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE | United Medical Systems, Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K891087 | TERUMO SURFLO(R) I.V. CATHETER | Terumo Medical Corp. | 1989-06-23 | Traditional | PDF ↗ |
| K884325 | SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-04-25 | Traditional | PDF ↗ |
| K890751 | ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT | Medical Safety Products, Inc. | 1989-04-21 | Traditional | PDF ↗ |
| K890435 | VITAACCESS CATHETER INTRODUCER KIT | Vitaphore Corp. | 1989-03-29 | Traditional | PDF ↗ |
| K884806 | LUMED EXPANDO-CATH, ACTIV | Luther Medical Products, Inc. | 1989-02-08 | Traditional | PDF ↗ |
| K884701 | CATH-FINDER SYSTEM | Pharmacia Deltec, Inc. | 1989-02-01 | Traditional | PDF ↗ |
| K883980 | LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES) | Menlo Care, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K883866 | NEOSOFT UMBILICAL VESSEL CATHETER | Menlo Care, Inc. | 1988-11-21 | Traditional | PDF ↗ |
| K884259 | MODIFIED LANDMARK VENOUS ACCESS DEVICE | Menlo Care, Inc. | 1988-11-01 | Traditional | PDF ↗ |
| K883415 | VASCULON 2 INTRAVENOUS CANNULA | Ohmeda Medical | 1988-10-04 | Traditional | PDF ↗ |
| K881767 | VIGGO INSUFLON | Ohmeda Medical | 1988-08-24 | Traditional | PDF ↗ |
| K881976 | CATHETER, INTRAVASCULAR | Primrose Medical, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K882242 | LANDMARK(TM) VENOUS ACCESS DEVICE | Menlo Care, Inc. | 1988-06-20 | Traditional | PDF ↗ |
| K881215 | CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH | Baxter Healthcare Corp | 1988-06-13 | Traditional | PDF ↗ |
| K881236 | TORAY ANTHRON P-U CATHETERS | Toray Industries (America), Inc. | 1988-05-11 | Traditional | PDF ↗ |
| K881666 | HR(TM) INTRAVASCULAR CATHETER | Icu Medical, Inc. | 1988-05-06 | Traditional | PDF ↗ |
| K880260 | SAFECATH | Phase Medical Systems, Inc. | 1988-04-19 | Traditional | PDF ↗ |
| K872998 | VITAACCESS (TM) CATHETER INTRODUCER SYSTEM | Vitaphore Corp. | 1988-03-24 | Traditional | PDF ↗ |
Product code FOZ · Class II · General Hospital. Data: openFDA.