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 5 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K875082 | O.P.C. INTRAVASCULAR CATHETER | Taut, Inc. | 1988-03-08 | Traditional | PDF ↗ |
| K875177 | J&J SCALP VEIN INFUSION SETS | Critikon Company, LLC | 1988-01-14 | Traditional | PDF ↗ |
| K874582 | DESERET SPLITTABLE CATHETER | Deseret Medical, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K873050 | VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF | C.R. Bard, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K872585 | CHURCHILL-CATH | Churchill Corp. | 1987-10-15 | Traditional | PDF ↗ |
| K871546 | SAFESIDE(TM) LUMED | Luther Medical Products, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | Burron Medical Products, Inc. | 1987-05-01 | Traditional | PDF ↗ |
| K864949 | INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER | Quinton, Inc. | 1987-02-25 | Traditional | PDF ↗ |
| K862153 | ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE | Arrow Intl., Inc. | 1986-12-11 | Traditional | PDF ↗ |
| K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT | Parke-Davis Co. | 1986-12-04 | Traditional | PDF ↗ |
| K864038 | SUPERCATH I.V. CATHETER | Togo Medikit Co., Ltd. | 1986-12-04 | Traditional | PDF ↗ |
| K862130 | COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. | Menlo Care, Inc. | 1986-08-14 | Traditional | PDF ↗ |
| K862480 | BT CATH (INTRAVASCULAR CATHETER) | Baron Technologies, Inc. | 1986-07-31 | Traditional | PDF ↗ |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | Burron Medical Products, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K861117 | ANTHRON CATHETERS & SETS | Toray Industries (America), Inc. | 1986-06-18 | Traditional | PDF ↗ |
| K861510 | MULTILUMEN VIAPIC CENTRAL LINE CATHETER | Warner-Lambert Co. | 1986-06-09 | Traditional | PDF ↗ |
| K860474 | STREAM LINE* I.V. CATHETER PLACEMENT UNIT | Menlo Care, Inc. | 1986-05-06 | Traditional | PDF ↗ |
| K853988 | FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI | Foran Industries, Inc. | 1986-05-01 | Traditional | PDF ↗ |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | Acme United Corp. | 1986-04-22 | Traditional | PDF ↗ |
| K854308 | POLYCATH-H CATHETER | Abbott Laboratories | 1986-04-07 | Traditional | PDF ↗ |
| K860256 | BRAWN AND GROSHONG CATHETERS | Catheter Technology Corp. | 1986-03-28 | Traditional | PDF ↗ |
| K860290 | VIAPIC CENTRAL LINE CATHETER | Parke-Davis Co. | 1986-03-18 | Traditional | PDF ↗ |
| K854566 | TERUMO SURFLO ETFE I.V. CATHETER | Terumo Medical Corp. | 1986-01-23 | Traditional | PDF ↗ |
| K853348 | L-CATH EXPANDO CATH | Luther Medical Products, Inc. | 1986-01-09 | Traditional | PDF ↗ |
| K853701 | JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL | Critikon Company, LLC | 1985-10-17 | Traditional | PDF ↗ |
| K851142 | TELET-LEX MEDICAL IV CATHETER PLACEMENT | Teleflexmedical, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K851981 | NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. | Superior Plastic Products Corp. | 1985-06-18 | Traditional | PDF ↗ |
| K851327 | DESERET ARTERIAL CATHETER | Parke-Davis Co. | 1985-06-14 | Traditional | PDF ↗ |
| K852078 | SPECTRUM(TENTATIVE) | Parke-Davis Co. | 1985-06-07 | Traditional | PDF ↗ |
| K844193 | QUINTON INJECTION SEALING CAP | Quinton, Inc. | 1985-05-17 | Traditional | PDF ↗ |
| K850887 | DRESSING CHANGE KIT | Creative Care Systems, Inc. | 1985-05-01 | Traditional | PDF ↗ |
| K850276 | VIGGO NEOFLON INFUSION CANNULA | Viggo Products | 1985-04-12 | Traditional | PDF ↗ |
| K851101 | BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET | Bionomy, Inc. | 1985-04-12 | Traditional | PDF ↗ |
| K850460 | VIGGO SECALON T CATHETER | Viggo Products | 1985-04-11 | Traditional | PDF ↗ |
| K850349 | VIGGO ARTERIAL CANNULA | Viggo Products | 1985-04-09 | Traditional | PDF ↗ |
| K850278 | VASCULON I.V. CANNULAE | Viggo Products | 1985-04-09 | Traditional | PDF ↗ |
| K850398 | NU-CATH EMERGENCY KIT | Intl. Medical Devices , Ltd. | 1985-03-27 | Traditional | PDF ↗ |
| K842577 | CATH-TECH POLYURETHANE UMBILICAL VESS | Catheter Technology Corp. | 1985-03-13 | Traditional | PDF ↗ |
| K842133 | EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS | Cardio Search, Inc. | 1985-02-19 | Traditional | PDF ↗ |
| K850369 | QUINTON WHITE SEALING CAP | Quinton, Inc. | 1985-02-15 | Traditional | PDF ↗ |
| K841880 | ERYTHROCATH UMBILICAL CATHETER | Cardio Search, Inc. | 1985-01-14 | Traditional | PDF ↗ |
| K843033 | DESERET INTRAVASCULAR CATHETER | Parke-Davis Co. | 1984-12-03 | Traditional | PDF ↗ |
| K844219 | DESERET DENTRAL LINE CATHETER | Parke-Davis Co. | 1984-11-28 | Traditional | PDF ↗ |
| K844113 | DESERET SUBCLAVIAN JUGULAR CATHETER SET | Parke-Davis Co. | 1984-11-28 | Traditional | PDF ↗ |
| K840815 | LUER LOCKING ADAPTER(MATERIAL CHANGE) | Quinton, Inc. | 1984-11-08 | Traditional | PDF ↗ |
| K840116 | DESERET INFANT CENTRAL VENOUS CATHE- | Parke-Davis Co. | 1984-03-22 | Traditional | PDF ↗ |
| K840355 | DESERET MULTILUMEN SUBCLAVIAN JUGULAR | Parke-Davis Co. | 1984-03-19 | Traditional | PDF ↗ |
| K840183 | DESERET MULTILUMEN SUBCLAVIAN JUGULAR | Parke-Davis Co. | 1984-03-19 | Traditional | PDF ↗ |
| K834227 | DESERET SUBCLAVIAN JUGULAR CATH. SET | Parke-Davis Co. | 1984-03-19 | Traditional | PDF ↗ |
| K840862 | DESERET CENTRAL VENOUS CATHETER | Parke-Davis Co. | 1984-03-19 | Traditional | PDF ↗ |
| K834255 | PBC SCALP VEIN SET | Philadelphia Biologics Center | 1984-03-12 | Traditional | PDF ↗ |
| K834073 | CENTRAL VEIN CATHERIZATION TRAY CC-20 | Packaging Technologies, Inc. | 1984-02-28 | Traditional | PDF ↗ |
| K834393 | DESERET NEONATAL CATHETER SET | Parke-Davis Co. | 1984-02-13 | Traditional | PDF ↗ |
| K834480 | INJECTION CAP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-02-04 | Traditional | PDF ↗ |
| K833079 | CENTRACATH #130,135 & 137-HEMOCATH # | Exco, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K833657 | ANGIO-SET INTRAVENOUS CATH. SET | Deseret Medical, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K832558 | RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV | Deseret Medical, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K833135 | INTRACATH INTRAVENOUS CATHETER UNIT | Parke-Davis Co. | 1983-11-21 | Traditional | PDF ↗ |
| K833092 | DESERET ANGIO-GUIDE LARGE VEIN CATH. | Warner-Lambert Co. | 1983-11-21 | Traditional | PDF ↗ |
| K833091 | DESERET SUBCLAVIAN JUGULAR CATH-SET | Warner-Lambert Co. | 1983-11-21 | Traditional | PDF ↗ |
| K832624 | TOP VENULA I.V. CATHETER SET | Top Surgical Manufacturers Co. | 1983-11-21 | Traditional | PDF ↗ |
| K830541 | INJECTION SEALING CAP 13791 | Quinton, Inc. | 1983-08-08 | Traditional | PDF ↗ |
| K830972 | I.V. CATHETER PLACEMENT UNIT POLYURETH | Critikon Company, LLC | 1983-04-27 | Traditional | PDF ↗ |
| K830765 | WINGED CATHETER | Abbott Laboratories | 1983-03-31 | Traditional | PDF ↗ |
| K830573 | PRE VUE | Taut, Inc. | 1983-03-29 | Traditional | PDF ↗ |
| K830539 | INTRAVASCULAR CATHETER SET | Lab-A-Cath Corp. | 1983-03-17 | Traditional | PDF ↗ |
| K823565 | MULTI-LUMEN INTRAVENOUS CATHETER | Mcpherson Enterprises, Inc. | 1982-12-16 | Traditional | PDF ↗ |
| K823351 | CENTRAL VENOUS CATHETER | Plasmedics, Inc. | 1982-12-09 | Traditional | PDF ↗ |
| K822776 | TEFLON CANNULA | Cardiac Pacemakers, Inc. | 1982-11-03 | Traditional | PDF ↗ |
| K823017 | INTRAVENOUS CATHETER PLACEMENT UNIT & | Access Devices, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822023 | DESERET SUBCLAVIAN JUGULAR CATH. SET | Warner-Lambert Co. | 1982-07-28 | Traditional | PDF ↗ |
| K821929 | SUBCLAVIAN | Dna Medical, Inc. | 1982-07-08 | Traditional | PDF ↗ |
| K821679 | LEONARD/NORTON HYPERALIMENTATION CATHET. | Norton Performance Plastics Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K821699 | DESERET SUBCLAVIAN JUGULAR CATHETER SET | Warner-Lambert Co. | 1982-06-24 | Traditional | PDF ↗ |
| K821577 | DESERET ANGIO GUIDE | Warner-Lambert Co. | 1982-06-16 | Traditional | PDF ↗ |
| K821371 | DESERET SUBCLAVIAN JUGULAR CATHETER SET | Warner-Lambert Co. | 1982-06-02 | Traditional | PDF ↗ |
| K821372 | DESERET INTRACATH INTRAVENOUS CATHETER | Warner-Lambert Co. | 1982-06-02 | Traditional | PDF ↗ |
| K813374 | NUTRICATH | Exco, Inc. | 1982-03-15 | Traditional | PDF ↗ |
| K813345 | CRITIKON I.V. CATHETER PLACEMENT UNIT | Critikon Company, LLC | 1982-01-12 | Traditional | PDF ↗ |
| K813396 | VERSCHLUBSTOPFEN COMB-CLOSING STOPPER | Burron Medical Products, Inc. | 1982-01-12 | Traditional | PDF ↗ |
| K812137 | B-D HEPARINIZED LONGDWEL I.V. CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-11-06 | Traditional | PDF ↗ |
| K812159 | INTRAVASCULAR CATHETER | Pioneer Viggo, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K811171 | VASCULON II I.V. CATHETER | Pioneer Viggo, Inc. | 1981-05-27 | Traditional | PDF ↗ |
| K803238 | INTRAVASCULAR CATHETER | G.D. Searle and Co. | 1981-04-23 | Traditional | PDF ↗ |
| K802918 | ANTHRON CATHETER SET | National Catheter Co. Div. Mallinckrodt | 1981-04-21 | Traditional | PDF ↗ |
| K801537 | START IT WITH & WITHOUT I.V. CATH. UNIT | Pioneer Viggo, Inc. | 1980-09-19 | Traditional | PDF ↗ |
| K801941 | BURRON MICROCATH INTRA. CATH. PLACEMENTT | Burron Medical Products, Inc. | 1980-08-27 | Traditional | PDF ↗ |
| K801575 | L-CATH INTRAVENOUS PLACEMENT UNIT | Luther Medical Products, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K801414 | ERYTHROCATH INTRAVENOUS CATHETER PLA. U. | G.D. Searle and Co. | 1980-08-13 | Traditional | PDF ↗ |
| K800786 | INJECTION SITE, CODE NO. 3100 | Quest Medical, Inc. | 1980-05-08 | Traditional | PDF ↗ |
| K800525 | MEDICAL COMPONENTS IV CATHETER | Medical Components, Inc. | 1980-04-08 | Traditional | PDF ↗ |
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | Jelco Laboratories | 1979-10-02 | Traditional | PDF ↗ |
| K790914 | SILASTIC INTRAVENOUS CATHETER UNIT | Dow Corning Corp. Healthcare Industries Materials | 1979-07-03 | Traditional | PDF ↗ |
| K790967 | CATHETER METAL HUB/RADIOPAQUE | Jelco Laboratories | 1979-06-27 | Traditional | PDF ↗ |
| K772011 | WHOLEY OCCLUSION BALLOON CATHETER | Cook, Inc. | 1979-06-15 | Traditional | PDF ↗ |
| K790968 | CATHETER METAL HUB/NONRADIOPAQUE | Jelco Laboratories | 1979-06-11 | Traditional | PDF ↗ |
| K780350 | I.V. START KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-27 | Traditional | PDF ↗ |
| K780105 | NEEDLE CONNECTING SET, BLUNT | Abbott Laboratories | 1978-02-21 | Traditional | PDF ↗ |
| K772354 | I.V. CATHETER | Ndm Corp. | 1978-01-31 | Traditional | PDF ↗ |
| K771381 | IV CATHETER HUB | Jelco Laboratories | 1977-10-13 | Traditional | PDF ↗ |
Product code FOZ · Class II · General Hospital. Data: openFDA.