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
241–264 of 507
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
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
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 06, 1995
CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY
K945521
Menlo Care, Inc.
General Hospital · 147d
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 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