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..
508
Total
508
Cleared
143d
Avg days
1976
Since
508 devices
Cleared
Sep 22, 2011
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
Vascular Pathways, Inc.
General Hospital
38d
Cleared
Aug 30, 2011
INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
B.Braun Melsungen AG
General Hospital
120d
Cleared
Jul 19, 2011
BD INSYTE AUTOGUARD BC
Becton, Dickinson & CO
General Hospital
153d
Cleared
Jan 06, 2011
BD NEXIVA CLOSED IV CATHETER SYSTEM
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
126d
Cleared
Jun 03, 2010
BD INTIMA II CLOSED IV CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
77d
Cleared
May 06, 2010
SPECTRUM TURBO-JECT PICC SET
Cook Incorporated
General Hospital
28d
Cleared
Feb 26, 2010
TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
Terumo Corp.
General Hospital
25d
Cleared
Dec 17, 2009
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
Togo Medikit Co., Ltd.
General Hospital
30d
Cleared
Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
Edwards Lifesciences, LLC
General Hospital
125d
Cleared
Sep 25, 2009
SNM FIRMGRIP
Flexicath , Ltd.
General Hospital
29d
Cleared
Aug 07, 2009
I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT
Weihai Jierui Medical Products Co., Ltd.
General Hospital
261d
Cleared
May 01, 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
Terumo Corp.
General Hospital
25d
Cleared
Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
Terumo Medical Corp.
General Hospital
189d
Cleared
Mar 12, 2009
SUPERCATH 5
Togo Medikit Co., Ltd.
General Hospital
246d
Cleared
Mar 10, 2009
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
U.S. Safety Syringes Co., Inc.
General Hospital
13d
Cleared
Feb 05, 2009
NUOVOGUARD
U.S. Safety Syringes Co., Inc.
General Hospital
15d
Cleared
Dec 04, 2008
NUOVOCATH
U.S. Safety Syringes Co., Inc.
General Hospital
13d
Cleared
Nov 07, 2008
VANISHPOINT I.V. CATHETER
Retractable Technologies, Inc.
General Hospital
171d
Cleared
Oct 16, 2008
FIRMGRIP
Flexicath , Ltd.
General Hospital
210d
Cleared
Sep 17, 2008
SURSHIELD SAFETY I.V. CATHETER
Terumo Medical Corp.
General Hospital
30d
Cleared
Jul 30, 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
Cook, Inc.
General Hospital
103d
Cleared
Jul 14, 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
Cook, Inc.
General Hospital
27d
Cleared
Apr 30, 2008
VANTAGECATH INTRAVASCULAR CATHETER
Advantage Medical Device
General Hospital
141d
Cleared
Apr 11, 2008
ANGIOTECH CVC
Angiotech Pharmaceuticals, Inc.
General Hospital
119d