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
May 12, 2014
SUPERCATH5
Togo Medikit Co., Ltd.
General Hospital
83d
Cleared
Feb 14, 2014
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
Nipro Medical Corporation
General Hospital
28d
Cleared
Jan 31, 2014
MEDSOURCE IV SAFETY CATHETER
Medsource International, LLC
General Hospital
247d
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
Apr 30, 2013
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
Luther Needlesafe Products, Inc.
General Hospital
62d
Cleared
Mar 05, 2013
JMS SAFE WING CATH (SWC)
JMS North America Corporation
General Hospital
291d
Cleared
Jan 17, 2013
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
43d
Cleared
Dec 28, 2012
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
Delta Med Srl
General Hospital
269d
Cleared
Nov 02, 2012
SURFFLASH(R) PLUS SAFETY I.V. CATHETER
Kofu Factory of Terumo Corp.
General Hospital
14d
Cleared
Sep 05, 2012
TERUMO SURFLASH SAFETY I.V. CATHETER
Terumo Corporation
General Hospital
15d
Cleared
Jul 20, 2012
NOVACATH SECURE IV CATHETER SYSTEM-18G
Tangent Medical Technologies, Inc.
General Hospital
122d
Cleared
Jul 11, 2012
M/29TM - PRESSURE INJECTABLE
Flexicath , Ltd.
General Hospital
369d
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
May 18, 2012
ORION II CT CVC
Health Line International Corporation (Hlic)
General Hospital
162d
Cleared
Apr 16, 2012
SUPERCATH Z3V
Togo Medikit Co., Ltd.
General Hospital
251d
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
Feb 16, 2012
I-PORT ADVANCE INJECTION PORT
Unomedical A/S
General Hospital
13d
Cleared
Feb 08, 2012
YOMURA SAFETY I.V. CATHETER
Yomura Technologies, Inc.
General Hospital
160d
Cleared
Dec 21, 2011
AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
Ameco Medical Industries
General Hospital
274d
Cleared
Sep 30, 2011
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
Becton, Dickinson and Company (BD)
General Hospital
137d
Cleared
Sep 22, 2011
RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
Vascular Pathways, Inc.
General Hospital
38d