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
337–360 of 507
Cleared Jul 01, 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
K861479
Burron Medical Products, Inc.
General Hospital · 70d
Cleared Jun 18, 1986
ANTHRON CATHETERS & SETS
K861117
Toray Industries (America), Inc.
General Hospital · 85d
Cleared Jun 09, 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510
Warner-Lambert Co.
General Hospital · 47d
Cleared May 06, 1986
STREAM LINE* I.V. CATHETER PLACEMENT UNIT
K860474
Menlo Care, Inc.
General Hospital · 88d
Cleared Apr 22, 1986
ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
K861015
Acme United Corp.
General Hospital · 35d
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 Jan 09, 1986
L-CATH EXPANDO CATH
K853348
Luther Medical Products, Inc.
General Hospital · 150d
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