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 07, 2020
MedSource CathMED IV Catheter
Medsource Labs
General Hospital
254d
Cleared
Apr 23, 2020
MF SAFECATH
Medifirst Co., Ltd.
General Hospital
251d
Cleared
Apr 07, 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
Bard Access Systems, Inc. (Bard Has Joined Bd)
General Hospital
64d
Cleared
Apr 01, 2020
Introcan Safety 2 IV Catheter 18-24 gauge
B.Braun Medical, Inc.
General Hospital
188d
Cleared
Mar 12, 2020
Health Line CT Midline Catheter
Health Line International Corporation
General Hospital
38d
Cleared
Jan 24, 2020
BD Cathena (TM) Safety IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
135d
Cleared
Dec 10, 2019
Health Line CT CVC
Health Line International Corporation
General Hospital
85d
Cleared
Nov 01, 2019
BD Acute Central Line
Bard Access Systems, Inc. (Bard Has Joined Bd)
General Hospital
213d
Cleared
Sep 20, 2019
Supercath 5
Togo Medikit Co., Ltd.
General Hospital
261d
Cleared
Sep 18, 2019
AccuCath Ace Intravascular Catheter
C.R. Bard, Inc.
General Hospital
133d
Cleared
May 17, 2019
Cook Unimpregnated Central Venous Catheter
Cook Incorporated
General Hospital
270d
Cleared
Mar 20, 2019
BD Nexiva Closed IV Catheter System
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
103d
Cleared
Mar 07, 2019
Introcan Safety 3 Closed IV Catheter
B.Braun Medical, Inc.
General Hospital
146d
Cleared
Jan 16, 2019
Merit RadialFlo Arterial Catheter
Merit Medical Singapore Pte. , Ltd.
Cardiovascular
124d
Cleared
Mar 23, 2018
SUPERCATH 5 (26G)
Togo Medikit Co., Ltd.
General Hospital
217d
Cleared
Dec 21, 2017
Deltaven XiV Max, Deltaven XiV Max FF
Delta Med Spa
General Hospital
210d
Cleared
Dec 15, 2017
BD Nexiva Diffusics Closed IV Catheter Systems
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital
51d
Cleared
Sep 17, 2017
BD Cathena Safety IV Catheter
Becton, Dickinson and Company
General Hospital
30d
Cleared
Aug 17, 2017
BD Intima II PLUS Closed IV Catheter System
Becton, Dickinson and Company
General Hospital
27d
Cleared
Apr 28, 2017
Introcan Safety 3 Closed IV Catheter
B.Braun Melsungen AG
General Hospital
149d
Cleared
Mar 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
Becton, Dickinson and Company
General Hospital
36d
Cleared
Mar 08, 2017
Nipro SafeTouch IV Catheter
Nipro Medical Corporation
General Hospital
264d
Cleared
Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
Becton, Dickinson and Company
General Hospital
29d
Cleared
Feb 24, 2017
Arrow Endurance Extended Dwell Peripheral Catheter System
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
General Hospital
71d