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
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
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
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
Nov 30, 2007
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
Vygon Corp.
General Hospital
261d
Cleared
Nov 09, 2007
ADVANTIV SAFETY I.V. CATHETER
Smiths Medical Asd, Inc.
General Hospital
73d
Cleared
Aug 30, 2007
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
Arrow International, Inc.
General Hospital
86d
Cleared
Sep 29, 2006
MULTICATH EXPERT
Vygon Corp.
General Hospital
148d
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
Jan 19, 2006
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
Myco Medical Supplies, Inc.
General Hospital
491d
Cleared
Dec 09, 2005
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
Excelsior Medical Corp.
General Hospital
32d