FOZ · Class II · 21 CFR 880.5200

FDA Product Code FOZ: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

Under FDA product code FOZ, short-term intravascular therapeutic catheters are cleared for the delivery of medications and fluids directly into the vascular system.

These catheters provide temporary vascular access for the administration of drugs, fluids, blood products, or parenteral nutrition over periods of days to weeks. They include peripheral and central venous catheters used across inpatient and outpatient settings.

FOZ devices are Class II medical devices, regulated under 21 CFR 880.5200 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Becton Dickinson Infusion Therapy Systems, Inc., Menlo Care, Inc. and Parke-Davis Co..

507
Total
507
Cleared
142d
Avg days
1976
Since
507 devices
361–384 of 507
Cleared Feb 13, 1984
DESERET NEONATAL CATHETER SET
K834393
Parke-Davis Co.
General Hospital · 61d
Cleared Feb 04, 1984
INJECTION CAP
K834480
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 46d
Cleared Dec 29, 1983
CENTRACATH #130,135 & 137-HEMOCATH #
K833079
Exco, Inc.
General Hospital · 111d
Cleared Dec 27, 1983
ANGIO-SET INTRAVENOUS CATH. SET
K833657
Deseret Medical, Inc.
General Hospital · 70d
Cleared Nov 28, 1983
RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV
K832558
Deseret Medical, Inc.
General Hospital · 119d
Cleared Nov 21, 1983
DESERET SUBCLAVIAN JUGULAR CATH-SET
K833091
Warner-Lambert Co.
General Hospital · 70d
Cleared Nov 21, 1983
DESERET ANGIO-GUIDE LARGE VEIN CATH.
K833092
Warner-Lambert Co.
General Hospital · 70d
Cleared Nov 21, 1983
INTRACATH INTRAVENOUS CATHETER UNIT
K833135
Parke-Davis Co.
General Hospital · 68d
Cleared Aug 08, 1983
INJECTION SEALING CAP 13791
K830541
Quinton, Inc.
General Hospital · 167d
Cleared Apr 27, 1983
I.V. CATHETER PLACEMENT UNIT POLYURETH
K830972
Critikon Company, LLC
General Hospital · 30d
Cleared Mar 31, 1983
WINGED CATHETER
K830765
Abbott Laboratories
General Hospital · 21d
Cleared Nov 03, 1982
TEFLON CANNULA
K822776
Cardiac Pacemakers, Inc.
General Hospital · 50d
Cleared Jul 28, 1982
DESERET SUBCLAVIAN JUGULAR CATH. SET
K822023
Warner-Lambert Co.
General Hospital · 19d
Cleared Jul 02, 1982
LEONARD/NORTON HYPERALIMENTATION CATHET.
K821679
Norton Performance Plastics Corp.
General Hospital · 24d
Cleared Jun 24, 1982
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K821699
Warner-Lambert Co.
General Hospital · 16d
Cleared Jun 16, 1982
DESERET ANGIO GUIDE
K821577
Warner-Lambert Co.
General Hospital · 19d
Cleared Jun 02, 1982
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K821371
Warner-Lambert Co.
General Hospital · 23d
Cleared Jun 02, 1982
DESERET INTRACATH INTRAVENOUS CATHETER
K821372
Warner-Lambert Co.
General Hospital · 23d
Cleared Mar 15, 1982
NUTRICATH
K813374
Exco, Inc.
General Hospital · 104d
Cleared Jan 12, 1982
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345
Critikon Company, LLC
General Hospital · 48d
Cleared Jan 12, 1982
VERSCHLUBSTOPFEN COMB-CLOSING STOPPER
K813396
Burron Medical Products, Inc.
General Hospital · 39d
Cleared Nov 06, 1981
B-D HEPARINIZED LONGDWEL I.V. CATHETER
K812137
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 101d
Cleared Apr 23, 1981
INTRAVASCULAR CATHETER
K803238
G.D. Searle and Co.
General Hospital · 121d
Cleared Aug 27, 1980
BURRON MICROCATH INTRA. CATH. PLACEMENTT
K801941
Burron Medical Products, Inc.
General Hospital · 14d