FOZ · Class II · 21 CFR 880.5200

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., Bd Becton Dickinson Vacutainer Systems Preanalytic and C.R. Bard, Inc..

504
Total
504
Cleared
142d
Avg days
1976
Since
504 devices
25–48 of 504
Cleared Aug 31, 2023
OSPREY Closed IV Catheter System (OspreyV2)
K231626
Skydance Vascular, Inc.
General Hospital · 90d
Cleared Jun 23, 2023
Mais Central Venous Catheter
K221827
Saudi Mais Co. For Medical Products
General Hospital · 365d
Cleared May 05, 2023
Polyguard and Polyshield Safety IV Catheters
K230616
Poly Medicure Limited
General Hospital · 60d
Cleared Apr 14, 2023
OSPREY PERIPHERAL IV Catheter System
K223018
Skydance Vascular, Inc.
General Hospital · 197d
Cleared Feb 03, 2023
Cook® Spectrum® 2 MRC Central Venous Catheter
K223648
Cook Advanced Technologies
General Hospital · 59d
Cleared Dec 07, 2022
HydroMID 4F Single Lumen Midline Catheter
K220772
Access Vascular, Inc.
General Hospital · 266d
Cleared Sep 13, 2022
MagiCath II
K210929
Woo Young Medical Co., Ltd.
General Hospital · 533d
Cleared Aug 29, 2022
Leaderflex Mini and Leaderflex Nano
K212370
Vygon USA
General Hospital · 395d
Cleared Jun 23, 2022
Introcan Safety 2 IV Catheter
K220756
B.Braun Medical, Inc.
General Hospital · 100d
Cleared May 14, 2022
Introcan Safety IV Catheter
K220626
B.Braun Medical, Inc.
General Hospital · 71d
Cleared Mar 31, 2022
BD Cathena Safety IV Catheter
K220584
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 30d
Cleared Mar 25, 2022
Pluski Safe 1 Safety IV Catheter
K210037
Mediplus (India) Limited
General Hospital · 443d
Cleared Feb 11, 2022
B. Braun Introcan Safety 2 IV Catheter
K213664
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Oct 25, 2021
Introcan Safety 3 Closed IV Catheter
K213085
B.Braun Medical, Inc.
General Hospital · 31d
Cleared Jul 23, 2021
Disposable IV catheter
K202060
Shinva Ande Healthcare Apparatus Co., Ltd.
General Hospital · 361d
Cleared Jun 02, 2021
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
K200891
Becton, Dickinson and Company
General Hospital · 425d
Cleared Feb 08, 2021
HydroMID
K203069
Access Vascular, Inc.
General Hospital · 122d
Cleared Dec 18, 2020
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
K201075
Becton, Dickinson and Company
General Hospital · 240d
Cleared Nov 24, 2020
ACENT™ Central Venous Catheter
K193158
Global Medikit Limited
General Hospital · 376d
Cleared Sep 22, 2020
BD Cathena Safety IV Catheter
K201717
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 91d
Cleared Aug 26, 2020
Deltaven Fast Flash Closed I.V. Catheter Systems
K200373
Delta Med Spa
General Hospital · 194d
Cleared Aug 07, 2020
MedSource CathMED IV Catheter
K193278
Medsource Labs
General Hospital · 254d
Cleared Apr 23, 2020
MF SAFECATH
K192230
Medifirst Co., Ltd.
General Hospital · 251d
Cleared Apr 07, 2020
BD Centro Vena Acute Central Line (7 French Dual Lumen)
K200266
Bard Access Systems, Inc. (Bard Has Joined Bd)
General Hospital · 64d