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
Sep 23, 2005
VANISHPOINT I.V. CATHETER
Retractable Technologies, Inc.
General Hospital
122d
Cleared
Sep 09, 2005
I-PORT
Patton Medical Devices
General Hospital
9d
Cleared
Jun 09, 2005
SUPERCATH Z3V
Togo Medikit Co., Ltd.
General Hospital
142d
Cleared
Feb 04, 2005
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
Emmebi Srl
General Hospital
52d
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
Jul 22, 2004
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
Medix, Inc.
General Hospital
63d
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
Jan 14, 2004
MODIFICATION TO V-CATH POLY PICC
Hdc Corp.
General Hospital
34d
Cleared
Dec 30, 2003
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
Edwards Lifesciences, LLC
General Hospital
84d
Cleared
Nov 14, 2003
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
Nipro Medical Corp.
General Hospital
67d
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
Oct 18, 2002
NIPRO BIO-FLEX CATHETER
Nipro Medical Corp.
General Hospital
59d
Cleared
Sep 20, 2002
SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
Hdc Corp.
General Hospital
85d
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