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
193–216 of 506
Cleared Apr 07, 1986
POLYCATH-H CATHETER
K854308
Abbott Laboratories
General Hospital · 164d
Cleared Mar 18, 1986
VIAPIC CENTRAL LINE CATHETER
K860290
Parke-Davis Co.
General Hospital · 49d
Cleared Jan 23, 1986
TERUMO SURFLO ETFE I.V. CATHETER
K854566
Terumo Medical Corp.
General Hospital · 79d
Cleared Oct 17, 1985
JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
K853701
Critikon Company, LLC
General Hospital · 43d
Cleared Jul 05, 1985
TELET-LEX MEDICAL IV CATHETER PLACEMENT
K851142
Teleflexmedical, Inc.
General Hospital · 106d
Cleared Jun 14, 1985
DESERET ARTERIAL CATHETER
K851327
Parke-Davis Co.
General Hospital · 71d
Cleared Jun 07, 1985
SPECTRUM(TENTATIVE)
K852078
Parke-Davis Co.
General Hospital · 25d
Cleared May 17, 1985
QUINTON INJECTION SEALING CAP
K844193
Quinton, Inc.
General Hospital · 199d
Cleared Feb 15, 1985
QUINTON WHITE SEALING CAP
K850369
Quinton, Inc.
General Hospital · 15d
Cleared Dec 03, 1984
DESERET INTRAVASCULAR CATHETER
K843033
Parke-Davis Co.
General Hospital · 124d
Cleared Nov 28, 1984
DESERET SUBCLAVIAN JUGULAR CATHETER SET
K844113
Parke-Davis Co.
General Hospital · 36d
Cleared Nov 28, 1984
DESERET DENTRAL LINE CATHETER
K844219
Parke-Davis Co.
General Hospital · 28d
Cleared Nov 08, 1984
LUER LOCKING ADAPTER(MATERIAL CHANGE)
K840815
Quinton, Inc.
General Hospital · 255d
Cleared Mar 22, 1984
DESERET INFANT CENTRAL VENOUS CATHE-
K840116
Parke-Davis Co.
General Hospital · 71d
Cleared Mar 19, 1984
DESERET SUBCLAVIAN JUGULAR CATH. SET
K834227
Parke-Davis Co.
General Hospital · 104d
Cleared Mar 19, 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840183
Parke-Davis Co.
General Hospital · 62d
Cleared Mar 19, 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840355
Parke-Davis Co.
General Hospital · 53d
Cleared Mar 19, 1984
DESERET CENTRAL VENOUS CATHETER
K840862
Parke-Davis Co.
General Hospital · 24d
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 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