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
Nov 15, 2016
AccuCath Intravascular Catheter
C.R. Bard, Inc.
General Hospital
29d
Cleared
Nov 03, 2016
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
Medsource International, LLC
General Hospital
127d
Cleared
Sep 22, 2016
PowerGlide Pro Midline Catheter
C.R. Bard, Inc.
General Hospital
29d
Cleared
Sep 08, 2016
BioFlo Midline Catheter
Navilyst Medical, Inc.
General Hospital
63d
Cleared
Aug 29, 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
61d
Cleared
Aug 12, 2016
SUPERCATH 6
Togo Medikit Co., Ltd.
General Hospital
164d
Cleared
Jun 30, 2016
ViaValve Safety I.V. Catheter
Smiths Medical Asd, Inc.
General Hospital
150d
Cleared
Jun 02, 2016
PowerGlide Pro Midline Catheter
C.R. Bard, Inc.
General Hospital
203d
Cleared
Mar 11, 2016
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
Tangent Medical Technologies, Inc.
General Hospital
30d
Cleared
Dec 10, 2015
AccuCath Intravascular Catheter
C.R. Bard, Inc.
General Hospital
27d
Cleared
Nov 23, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
General Hospital
103d
Cleared
Jul 27, 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
33d
Cleared
Jul 15, 2015
MedSource ClearSafe Safety IV Catheter
Medsource International
General Hospital
127d
Cleared
Jul 08, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)
General Hospital
34d
Cleared
Jun 18, 2015
I.V. Catheter
Jiangxi Sanxin Medtec Co., Ltd.
General Hospital
262d
Cleared
Jun 05, 2015
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology
Arrow International (A Subsidiary of Teleflex, Inc.)
General Hospital
136d
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
Jan 08, 2015
ACCUCATH MIDLINE CATHETER SYSTEM
Vascular Pathways, Inc.
General Hospital
157d
Cleared
Aug 20, 2014
NEXUS MIDLINE CT CATHETER
Health Line International Corporation
General Hospital
198d
Cleared
Jul 30, 2014
LEADERFLEX
Vygon
General Hospital
99d
Cleared
Jul 17, 2014
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
Vascular Pathways, Inc.
General Hospital
140d
Cleared
Jun 12, 2014
TERUMO SURFLO I.V. CATHETER
Terumo (Philippines) Corporation
General Hospital
230d
Cleared
May 30, 2014
SURFLASH SAFETY I.V. CATHETER
Kofu Factory of Terumo Corp.
General Hospital
28d