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
385–408 of 507
Cleared Aug 20, 1980
L-CATH INTRAVENOUS PLACEMENT UNIT
K801575
Luther Medical Products, Inc.
General Hospital · 43d
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 Oct 02, 1979
JELCO WINGED INTRAVASCULAR CATHETER
K791918
Jelco Laboratories
General Hospital · 7d
Cleared Jul 03, 1979
SILASTIC INTRAVENOUS CATHETER UNIT
K790914
Dow Corning Corp. Healthcare Industries Materials
General Hospital · 50d
Cleared Jun 27, 1979
CATHETER METAL HUB/RADIOPAQUE
K790967
Jelco Laboratories
General Hospital · 36d
Cleared Jun 15, 1979
WHOLEY OCCLUSION BALLOON CATHETER
K772011
Cook, Inc.
General Hospital · 598d
Cleared Jun 11, 1979
CATHETER METAL HUB/NONRADIOPAQUE
K790968
Jelco Laboratories
General Hospital · 20d
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 Oct 13, 1977
IV CATHETER HUB
K771381
Jelco Laboratories
General Hospital · 79d
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
Cleared Aug 11, 1976
KIT, CATHETER
K760319
Jelco Laboratories
General Hospital · 16d
Cleared Jul 20, 1976
CATHETER, INTRAVASCULAR (MEDICUT T)
K760163
Sherwood Medical Industries
General Hospital · 20d