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
Dec 10, 2015
AccuCath Intravascular Catheter
C.R. Bard, Inc.
General Hospital
27d
Cleared
Jul 27, 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
33d
Cleared
May 15, 2015
BioFlo Midline Catheter
Navilyst Medical, Inc.
General Hospital
86d
Cleared
Apr 09, 2015
BD INTIMA II CLOSED IV CATHETER
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
111d
Cleared
Feb 14, 2014
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
Nipro Medical Corporation
General Hospital
28d
Cleared
Jan 16, 2014
POWERGLIDE MIDLINE CATHETER
C.R. Bard, Inc.
General Hospital
28d
Cleared
Dec 05, 2013
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
Nipro Medical Corporation
General Hospital
146d
Cleared
Jan 17, 2013
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
43d
Cleared
Jun 01, 2012
POWERGLIDE MIDLINE CATHETER
C.R. Bard, Inc.
General Hospital
53d
Cleared
May 18, 2012
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
Edwards Lifesciences, LLC
General Hospital
168d
Cleared
Mar 14, 2012
VIAVALVE SAFETY IV CATHETER
Smiths Medical Asd, Inc.
General Hospital
89d
Cleared
Mar 12, 2012
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
Nipro Medical Corporation
General Hospital
112d
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
Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
Edwards Lifesciences, LLC
General Hospital
125d
Cleared
Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
Terumo Medical Corp.
General Hospital
189d
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
Sep 29, 2006
MULTICATH EXPERT
Vygon Corp.
General Hospital
148d