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..

507
Total
507
Cleared
142d
Avg days
1976
Since
507 devices
289–312 of 507
Cleared Jun 03, 1991
VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
K910565
Menlo Care, Inc.
General Hospital · 115d
Cleared Jun 03, 1991
VERSACATH(TM) MULTILUMEN SYSTEM
K910566
Menlo Care, Inc.
General Hospital · 115d
Cleared May 06, 1991
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
K910564
Menlo Care, Inc.
General Hospital · 87d
Cleared Apr 29, 1991
INJECTION CAPS
K910572
Akcess Medical Products, Inc.
General Hospital · 77d
Cleared Mar 21, 1991
LANDMARK VENOUS ACCESS DEVICE
K910799
Menlo Care, Inc.
General Hospital · 24d
Cleared Feb 11, 1991
DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
K904558
Davol, Inc.
General Hospital · 129d
Cleared Dec 14, 1990
SAFE SYTE I.V. CATHETER PLACEMENT UNIT
K904648
Deseret Medical, Inc.
General Hospital · 64d
Cleared Nov 19, 1990
CATH-FINDER(TM) CATHETER TRACKING SYSTEM
K904150
Pharmacia Deltec, Inc.
General Hospital · 73d
Cleared Nov 08, 1990
VIALON OBTURATOR
K904121
Deseret Medical, Inc.
General Hospital · 63d
Cleared Oct 04, 1990
INSYTE-A ARTERIAL CATHETERIZATION UNIT
K904122
Deseret Medical, Inc.
General Hospital · 28d
Cleared Oct 03, 1990
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K903732
Kendall Healthcare Products Co. Div.Of Tyco Health
General Hospital · 48d
Cleared Sep 12, 1990
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
K895597
Vas-Cath, Inc.
General Hospital · 359d
Cleared Sep 12, 1990
SPLIT-SECOND INTRODUCER
K902527
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 99d
Cleared Aug 15, 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056
Abbott Laboratories
General Hospital · 224d
Cleared Aug 10, 1990
MULTICATH PLACEMENT KIT
K901640
Vygon Corp.
General Hospital · 123d
Cleared Jul 24, 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263
Arrow Intl., Inc.
General Hospital · 187d
Cleared Jul 02, 1990
GESCO DUAL LUMEN PER-Q-CATH-DL
K895942
Gesco Intl., Inc.
General Hospital · 264d
Cleared Jun 18, 1990
DESERET OPTIMA INTRAVASCULAR CATHETER
K900116
Deseret Medical, Inc.
General Hospital · 160d
Cleared Apr 09, 1990
DESERET INTRAVASCULAR CATHETER
K895734
Deseret Medical, Inc.
General Hospital · 195d
Cleared Feb 16, 1990
EXEL SAFELET CATHETER
K895768
Exel Intl.
General Hospital · 143d
Cleared Dec 27, 1989
STREAMLINE VASCULAR ACCESS DEVICE
K896774
Menlo Care, Inc.
General Hospital · 26d
Cleared Nov 01, 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546
Critikon Company, LLC
General Hospital · 174d
Cleared Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
K893965
Baxter Healthcare Corp
General Hospital · 98d
Cleared Aug 01, 1989
PROCEDURE READY TRAYS
K884577
Professional Medical Services
General Hospital · 273d