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., Parke-Davis Co. and B.Braun Medical, Inc..

506
Total
506
Cleared
142d
Avg days
1976
Since
506 devices
217–240 of 506
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 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
Cleared Aug 13, 1980
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414
G.D. Searle and Co.
General Hospital · 58d
Cleared May 08, 1980
INJECTION SITE, CODE NO. 3100
K800786
Quest Medical, Inc.
General Hospital · 30d
Cleared Apr 08, 1980
MEDICAL COMPONENTS IV CATHETER
K800525
Medical Components, Inc.
General Hospital · 32d
Cleared Jun 15, 1979
WHOLEY OCCLUSION BALLOON CATHETER
K772011
Cook, Inc.
General Hospital · 598d
Cleared Mar 27, 1978
I.V. START KIT
K780350
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 24d
Cleared Feb 21, 1978
NEEDLE CONNECTING SET, BLUNT
K780105
Abbott Laboratories
General Hospital · 32d
Cleared May 26, 1977
CATHETERS, OVER-THE-NEEDLE
K770751
Cutter Laboratories, Inc.
General Hospital · 31d
Cleared May 10, 1977
CANNULA, INTRAVENOUS, TEFLON
K770510
Sherwood Medical Industries
General Hospital · 54d
Cleared Apr 29, 1977
CANNULA, INTRAVENOUS, HEPARINIZED
K770511
Sherwood Medical Industries
General Hospital · 43d
Cleared Mar 16, 1977
CATHETER-THRU-NEEDLE DEVICE
K770403
Abbott Laboratories
General Hospital · 13d