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
Apr 14, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS)
C.R. Bard, Inc.
General Hospital
63d
Cleared
Apr 05, 2006
VYGON LEADER-FLEX
Vygon Corp.
General Hospital
198d
Cleared
Mar 02, 2006
VYGON LATEX FREE BIONECTOR
Vygon Corp.
General Hospital
141d
Cleared
Feb 17, 2006
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
Cook, Inc.
General Hospital
25d
Cleared
Dec 03, 2004
BD ONECATH
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
49d
Cleared
Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
Cook, Inc.
General Hospital
246d
Cleared
May 03, 2004
FIBREX CATHETER PATENCY DEVICE
Medical Device Technologies, Inc.
General Hospital
74d
Cleared
Feb 27, 2004
NEXIVA CLOSED IV CATHETER SYSTEM
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
169d
Cleared
Feb 26, 2004
COOK FIVE LUMEN CENTRAL VENOUS CATHETER
Cook, Inc.
General Hospital
218d
Cleared
Jan 29, 2004
BD CAREFLOW CENTRAL VENOUS CATHETER
Becton, Dickinson & CO
General Hospital
85d
Cleared
Dec 30, 2003
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
Edwards Lifesciences, LLC
General Hospital
84d
Cleared
Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
Arrow Intl., Inc.
General Hospital
36d
Cleared
May 30, 2003
SPECTRUM SILICONE CATHETER
Cook, Inc.
General Hospital
382d
Cleared
May 06, 2003
PEDIATRIC CENTRAL VENOUS CATHETER KIT
B.Braun Medical, Inc.
General Hospital
218d
Cleared
Mar 28, 2003
ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER
Ethicon Endo-Surgery, Inc.
General Hospital
32d
Cleared
Aug 28, 2002
INTROCAN SAFETY IV CATHETER
B.Braun Medical, Inc.
General Hospital
170d
Cleared
Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
Cook, Inc.
General Hospital
280d
Cleared
Apr 17, 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
Micro Therapeutics, Inc.
General Hospital
8d
Cleared
Dec 21, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
36d
Cleared
Nov 08, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
55d
Cleared
Aug 28, 2001
TRULINE INFUSION CATHETERS
Micro Therapeutics, Inc.
General Hospital
68d
Cleared
Aug 01, 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
Ethicon Endo-Surgery, Inc.
General Hospital
23d
Cleared
Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
124d
Cleared
Feb 23, 2001
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
Medical Components, Inc.
General Hospital
51d