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
Cleared
Jun 03, 1991
VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
Menlo Care, Inc.
General Hospital
115d
Cleared
Jun 03, 1991
VERSACATH(TM) MULTILUMEN SYSTEM
Menlo Care, Inc.
General Hospital
115d
Cleared
May 06, 1991
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
Menlo Care, Inc.
General Hospital
87d
Cleared
Apr 29, 1991
INJECTION CAPS
Akcess Medical Products, Inc.
General Hospital
77d
Cleared
Mar 21, 1991
LANDMARK VENOUS ACCESS DEVICE
Menlo Care, Inc.
General Hospital
24d
Cleared
Feb 11, 1991
DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
Davol, Inc.
General Hospital
129d
Cleared
Dec 14, 1990
SAFE SYTE I.V. CATHETER PLACEMENT UNIT
Deseret Medical, Inc.
General Hospital
64d
Cleared
Nov 19, 1990
CATH-FINDER(TM) CATHETER TRACKING SYSTEM
Pharmacia Deltec, Inc.
General Hospital
73d
Cleared
Nov 08, 1990
VIALON OBTURATOR
Deseret Medical, Inc.
General Hospital
63d
Cleared
Oct 04, 1990
INSYTE-A ARTERIAL CATHETERIZATION UNIT
Deseret Medical, Inc.
General Hospital
28d
Cleared
Oct 03, 1990
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
Kendall Healthcare Products Co. Div.Of Tyco Health
General Hospital
48d
Cleared
Sep 12, 1990
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
Vas-Cath, Inc.
General Hospital
359d
Cleared
Sep 12, 1990
SPLIT-SECOND INTRODUCER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
99d
Cleared
Aug 15, 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
Abbott Laboratories
General Hospital
224d
Cleared
Aug 10, 1990
MULTICATH PLACEMENT KIT
Vygon Corp.
General Hospital
123d
Cleared
Jul 24, 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Arrow Intl., Inc.
General Hospital
187d
Cleared
Jul 02, 1990
GESCO DUAL LUMEN PER-Q-CATH-DL
Gesco Intl., Inc.
General Hospital
264d
Cleared
Jun 18, 1990
DESERET OPTIMA INTRAVASCULAR CATHETER
Deseret Medical, Inc.
General Hospital
160d
Cleared
Apr 09, 1990
DESERET INTRAVASCULAR CATHETER
Deseret Medical, Inc.
General Hospital
195d
Cleared
Feb 16, 1990
EXEL SAFELET CATHETER
Exel Intl.
General Hospital
143d
Cleared
Dec 27, 1989
STREAMLINE VASCULAR ACCESS DEVICE
Menlo Care, Inc.
General Hospital
26d
Cleared
Nov 01, 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
Critikon Company, LLC
General Hospital
174d
Cleared
Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
Baxter Healthcare Corp
General Hospital
98d
Cleared
Aug 01, 1989
PROCEDURE READY TRAYS
Professional Medical Services
General Hospital
273d