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., Menlo Care, Inc. and Parke-Davis Co..

508
Total
508
Cleared
143d
Avg days
1976
Since
508 devices
289–312 of 508
Cleared May 23, 1995
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR
K950284
Sims Deltec, Inc.
General Hospital · 119d
Cleared May 19, 1995
LF CT HIG PRESSURE CATHETERS
K945053
Mallinckrodt Group, Inc.
General Hospital · 217d
Cleared Apr 18, 1995
ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS
K950301
Becton Dickinson Vascular Access, Inc.
General Hospital · 83d
Cleared Apr 10, 1995
THE FLEX-SET SUBCUTANEOUS INFUSION SET
K944302
Cathco, Inc.
General Hospital · 216d
Cleared Apr 06, 1995
CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY
K945521
Menlo Care, Inc.
General Hospital · 147d
Cleared Apr 05, 1995
CATCO UMBILICAL VESSEL CATHETER
K944336
Catco Medical, Inc.
General Hospital · 211d
Cleared Apr 05, 1995
CATCO POLYURETHANE UMBILICAL VESSEL CATHETER
K944367
Catco Medical, Inc.
General Hospital · 210d
Cleared Apr 05, 1995
CATCO SILICONE UMBILICAL VESSEL CATHETER
K944368
Catco Medical, Inc.
General Hospital · 210d
Cleared Apr 05, 1995
CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER
K944410
Catco Medical, Inc.
General Hospital · 209d
Cleared Mar 31, 1995
CATCO FIRST PICC
K944504
Catco Medical, Inc.
General Hospital · 198d
Cleared Mar 29, 1995
LANDMARK MIDLINE CATHETER
K944968
Menlo Care, Inc.
General Hospital · 169d
Cleared Mar 29, 1995
LANDMARK MIDLINE CATHETER
K950737
Menlo Care, Inc.
General Hospital · 41d
Cleared Mar 22, 1995
MAHURKAR DUAL LUMEN CATHETER
K943349
Quinton, Inc.
General Hospital · 253d
Cleared Mar 13, 1995
ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)
K944511
Neostar Medical Technologies, Inc.
General Hospital · 179d
Cleared Mar 13, 1995
ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY
K944660
Neostar Medical Technologies, Inc.
General Hospital · 173d
Cleared Jan 09, 1995
INSYTE INTRODUCER CATHETER
K942045
Becton Dickinson Vascular Access, Inc.
General Hospital · 256d
Cleared Dec 12, 1994
PRN ADAPTER
K933467
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 514d
Cleared Oct 14, 1994
CUFF-CATH
K935090
Ohmeda Medical
General Hospital · 357d
Cleared Oct 14, 1994
MICRO THERAPEUTICS INFUSION CATHETER
K940634
Micro Therapeutics, Inc.
General Hospital · 242d
Cleared Oct 06, 1994
VITAFLON PLUS/VASCULON
K941417
Hogan & Hartson
General Hospital · 197d
Cleared Sep 30, 1994
CVD BULLETT PERIPHERAL INFUSION CATHETER
K943023
Cardiovascular Dynamics, Inc.
General Hospital · 98d
Cleared Jul 28, 1994
ONE-SITE IV CONNECTOR
K932789
Care Medical Devices, Inc.
General Hospital · 414d
Cleared Jun 15, 1994
INJECTION CAP
K940775
Medron, Inc.
General Hospital · 113d
Cleared Jun 10, 1994
DIAL MEDICAL SUPPLY FISTULA NEEDLE SET
K940441
Dial Medical of Florida, Inc.
General Hospital · 130d