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
Cleared
Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
Cook, Inc.
General Hospital
20d
Cleared
Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
Baxter Healthcare Corp
General Hospital
48d
Cleared
Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
Abbott Laboratories
General Hospital
63d
Cleared
Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
21d
Cleared
Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
Baxter Healthcare Corp
General Hospital
320d
Cleared
Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
69d
Cleared
Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
The Kendal Co.
General Hospital
65d
Cleared
Mar 08, 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Arrow Intl., Inc.
General Hospital
128d
Cleared
Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
Baxter Healthcare Corp
General Hospital
283d
Cleared
Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
Cook, Inc.
General Hospital
58d
Cleared
Jun 16, 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
Terumo Medical Corp.
General Hospital
55d
Cleared
Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
147d
Cleared
Jan 14, 1999
INTROCAN SAFETY IV CATHETER
B.Braun Medical, Inc.
General Hospital
157d
Cleared
Dec 16, 1998
BRAUN PREFILLED SYRINGE
B.Braun Medical, Inc.
General Hospital
656d
Cleared
Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
Boston Scientific Corp
General Hospital
213d
Cleared
May 18, 1998
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
Davis & Geck, Inc.
General Hospital
208d
Cleared
May 11, 1998
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
Medical Components, Inc.
General Hospital
234d
Cleared
Apr 28, 1998
I.V. CATHETER SYSTEM
Johnson & Johnson Medical, Inc.
General Hospital
78d
Cleared
Feb 26, 1998
INTROSYTE CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
69d
Cleared
Oct 17, 1997
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
Arrow Intl., Inc.
General Hospital
221d
Cleared
Sep 15, 1997
FIRST PICC CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
90d
Cleared
Sep 15, 1997
FIRST PICC CATHETER WITH DUAL LUMENS
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
90d
Cleared
Sep 15, 1997
FIRST MIDCATH CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
90d
Cleared
Sep 12, 1997
FIRST MIDCATH CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
88d