ClearanceBrief
Panels › General Hospital › Product code FOZ · Class 2

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Regulation 880.5200

8510(k)s in 12 months (508 all time)
6recalls in 12 months (394 all time)
359recalls that name a 510(k)
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Top companies in FOZ

Company510(k)sRecalls
Arrow International, Inc.1155
Cook Incorporated13123
Becton Dickinson Infusion Therapy Systems, Inc.3015
Menlo Care, Inc.220
Am2 Pat, Inc.115
B.Braun Medical, Inc.122
Delta Med Spa311
Parke-Davis Co.140
Becton Dickinson Medical Systems012
Becton Dickinson Vascular Access, Inc.110
Decided510(k)Device and applicantCode
Mar 12, 1984K834255PBC SCALP VEIN SET
Philadelphia Biologics Center
FOZ
Feb 28, 1984K834073CENTRAL VEIN CATHERIZATION TRAY CC-20
Packaging Technologies, Inc.
FOZ
Feb 13, 1984K834393DESERET NEONATAL CATHETER SET
Parke-Davis Co.
FOZ
Feb 4, 1984K834480INJECTION CAP
Bd Becton Dickinson Vacutainer Systems Preanalytic
FOZ
Dec 29, 1983K833079CENTRACATH #130,135 & 137-HEMOCATH #
Exco, Inc.
FOZ
Dec 27, 1983K833657ANGIO-SET INTRAVENOUS CATH. SET
Deseret Medical, Inc.
FOZ
Nov 28, 1983K832558RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV
Deseret Medical, Inc.
FOZ
Nov 21, 1983K833135INTRACATH INTRAVENOUS CATHETER UNIT
Parke-Davis Co.
FOZ
Nov 21, 1983K833092DESERET ANGIO-GUIDE LARGE VEIN CATH.
Warner-Lambert Co.
FOZ
Nov 21, 1983K833091DESERET SUBCLAVIAN JUGULAR CATH-SET
Warner-Lambert Co.
FOZ
Nov 21, 1983K832624TOP VENULA I.V. CATHETER SET
Top Surgical Manufacturers Co.
FOZ
Aug 8, 1983K830541INJECTION SEALING CAP 13791
Quinton, Inc.
FOZ
Apr 27, 1983K830972I.V. CATHETER PLACEMENT UNIT POLYURETH
Critikon Company, LLC
FOZ
Mar 31, 1983K830765WINGED CATHETER
Abbott Laboratories
FOZ
Mar 29, 1983K830573PRE VUE
Taut, Inc.
FOZ
Mar 17, 1983K830539INTRAVASCULAR CATHETER SET
Lab-A-Cath Corp.
FOZ
Dec 16, 1982K823565MULTI-LUMEN INTRAVENOUS CATHETER
Mcpherson Enterprises, Inc.
FOZ
Dec 9, 1982K823351CENTRAL VENOUS CATHETER
Plasmedics, Inc.
FOZ
Nov 3, 1982K822776TEFLON CANNULA
Cardiac Pacemakers, Inc.
FOZ
Nov 1, 1982K823017INTRAVENOUS CATHETER PLACEMENT UNIT &
Access Devices, Inc.
FOZ
Jul 28, 1982K822023DESERET SUBCLAVIAN JUGULAR CATH. SET
Warner-Lambert Co.
FOZ
Jul 8, 1982K821929SUBCLAVIAN
Dna Medical, Inc.
FOZ
Jul 2, 1982K821679LEONARD/NORTON HYPERALIMENTATION CATHET.
Norton Performance Plastics Corp.
FOZ
Jun 24, 1982K821699DESERET SUBCLAVIAN JUGULAR CATHETER SET
Warner-Lambert Co.
FOZ
Jun 16, 1982K821577DESERET ANGIO GUIDE
Warner-Lambert Co.
FOZ
Jun 2, 1982K821372DESERET INTRACATH INTRAVENOUS CATHETER
Warner-Lambert Co.
FOZ
Jun 2, 1982K821371DESERET SUBCLAVIAN JUGULAR CATHETER SET
Warner-Lambert Co.
FOZ
Mar 15, 1982K813374NUTRICATH
Exco, Inc.
FOZ
Jan 12, 1982K813396VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
Burron Medical Products, Inc.
FOZ
Jan 12, 1982K813345CRITIKON I.V. CATHETER PLACEMENT UNIT
Critikon Company, LLC
FOZ
Nov 6, 1981K812137B-D HEPARINIZED LONGDWEL I.V. CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
FOZ
Aug 31, 1981K812159INTRAVASCULAR CATHETER
Pioneer Viggo, Inc.
FOZ
May 27, 1981K811171VASCULON II I.V. CATHETER
Pioneer Viggo, Inc.
FOZ
Apr 23, 1981K803238INTRAVASCULAR CATHETER
G.D. Searle and Co.
FOZ
Apr 21, 1981K802918ANTHRON CATHETER SET
National Catheter Co. Div. Mallinckrodt
FOZ
Sep 19, 1980K801537START IT WITH & WITHOUT I.V. CATH. UNIT
Pioneer Viggo, Inc.
FOZ
Aug 27, 1980K801941BURRON MICROCATH INTRA. CATH. PLACEMENTT
Burron Medical Products, Inc.
FOZ
Aug 20, 1980K801575L-CATH INTRAVENOUS PLACEMENT UNIT
Luther Medical Products, Inc.
FOZ
Aug 13, 1980K801414ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
G.D. Searle and Co.
FOZ
May 8, 1980K800786INJECTION SITE, CODE NO. 3100
Quest Medical, Inc.
FOZ
Apr 8, 1980K800525MEDICAL COMPONENTS IV CATHETER
Medical Components, Inc.
FOZ
Oct 2, 1979K791918JELCO WINGED INTRAVASCULAR CATHETER
Jelco Laboratories
FOZ
Jul 3, 1979K790914SILASTIC INTRAVENOUS CATHETER UNIT
Dow Corning Corp. Healthcare Industries Materials
FOZ
Jun 27, 1979K790967CATHETER METAL HUB/RADIOPAQUE
Jelco Laboratories
FOZ
Jun 15, 1979K772011WHOLEY OCCLUSION BALLOON CATHETER
Cook, Inc.
FOZ
Jun 11, 1979K790968CATHETER METAL HUB/NONRADIOPAQUE
Jelco Laboratories
FOZ
Mar 27, 1978K780350I.V. START KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
FOZ
Feb 21, 1978K780105NEEDLE CONNECTING SET, BLUNT
Abbott Laboratories
FOZ
Jan 31, 1978K772354I.V. CATHETER
Ndm Corp.
FOZ
Oct 13, 1977K771381IV CATHETER HUB
Jelco Laboratories
FOZ

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