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
265–288 of 508
Cleared Nov 06, 1996
NEO-CARE CATHETERIZATION TRAY
K963867
Klein-Baker Medical, Inc.
General Hospital · 41d
Cleared Oct 25, 1996
EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
K962938
Excelsior Medical Corp.
General Hospital · 88d
Cleared Jul 25, 1996
MEDCOMP P-CATH
K953811
Medcomp
General Hospital · 365d
Cleared Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
K953805
Abbott Laboratories
General Hospital · 325d
Cleared May 09, 1996
VYGON LIFEVAC MID-LINE TRAY
K954112
Vygon Corp.
General Hospital · 283d
Cleared Apr 04, 1996
MIDMARK MIDLINE CATHETER
K951620
Menlo Care, Inc.
General Hospital · 363d
Cleared Mar 28, 1996
SOLOPICC 24 (60CM) 20GA CATHETER
K954428
Douglas Medical Products Corp.
General Hospital · 188d
Cleared Mar 28, 1996
NIPRO SAFELET CATH
K960051
Nissho Corp.
General Hospital · 84d
Cleared Mar 25, 1996
MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
K955839
Baxter Edwards
General Hospital · 90d
Cleared Feb 13, 1996
MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM
K960013
MDC Research , Ltd.
General Hospital · 42d
Cleared Feb 08, 1996
ABRM CATHETER
K950118
Cook, Inc.
General Hospital · 393d
Cleared Jan 24, 1996
STERILE WATER O.9% STERILE SALINE
K954887
Lockett Medical Corp.
General Hospital · 100d
Cleared Jan 23, 1996
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER
K953335
Micro Therapeutics, Inc.
General Hospital · 190d
Cleared Jan 04, 1996
NIPRO SCALP VEIN SET (DISPOSABL PSV SET)
K955053
Nissho Corp.
General Hospital · 59d
Cleared Dec 13, 1995
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE
K952645
Vital Signs, Inc.
General Hospital · 187d
Cleared Dec 13, 1995
VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE
K953120
Vital Signs, Inc.
General Hospital · 161d
Cleared Nov 03, 1995
COMFORT-Q SUBCUTANEOUS INJECTION SETS
K946170
B. Braun of America, Inc.
General Hospital · 319d
Cleared Sep 21, 1995
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
K952058
Trinity Laboratories, Inc.
General Hospital · 142d
Cleared Sep 01, 1995
WALLACE IV CANNULA
K932946
Smiths Industries Medical Systems, Inc.
General Hospital · 806d
Cleared Sep 01, 1995
WALLACE Y-CAN
K932947
Smiths Industries Medical Systems, Inc.
General Hospital · 806d
Cleared Jul 31, 1995
PICC LINE KIT
K952256
Medi-Flex Hospital Products, Inc.
General Hospital · 77d
Cleared Jul 31, 1995
ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER
K952757
Becton Dickinson Vascular Access, Inc.
General Hospital · 45d
Cleared Jul 31, 1995
ANGIOCATH & INSYTE AUTOGUARD CATHETERS
K952861
Becton Dickinson Vascular Access, Inc.
General Hospital · 39d
Cleared Jun 26, 1995
BIONECTOR
K941678
Vygon Corp.
General Hospital · 447d