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., Parke-Davis Co. and B.Braun Medical, Inc..

506
Total
506
Cleared
142d
Avg days
1976
Since
506 devices
121–144 of 506
Cleared Jan 24, 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034
Cook, Inc.
General Hospital · 20d
Cleared Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
K003245
Baxter Healthcare Corp
General Hospital · 48d
Cleared Jul 27, 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616
Abbott Laboratories
General Hospital · 63d
Cleared Jul 26, 2000
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS
K002033
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 21d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
K992532
Baxter Healthcare Corp
General Hospital · 320d
Cleared Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
K000235
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 69d
Cleared Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
K000087
The Kendal Co.
General Hospital · 65d
Cleared Mar 08, 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K993691
Arrow Intl., Inc.
General Hospital · 128d
Cleared Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590
Baxter Healthcare Corp
General Hospital · 283d
Cleared Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
K992198
Cook, Inc.
General Hospital · 58d
Cleared Jun 16, 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
K991406
Terumo Medical Corp.
General Hospital · 55d
Cleared Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
K984059
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 147d
Cleared Jan 14, 1999
INTROCAN SAFETY IV CATHETER
K982805
B.Braun Medical, Inc.
General Hospital · 157d
Cleared Dec 16, 1998
BRAUN PREFILLED SYRINGE
K970736
B.Braun Medical, Inc.
General Hospital · 656d
Cleared Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566
Boston Scientific Corp
General Hospital · 213d
Cleared May 18, 1998
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
K974015
Davis & Geck, Inc.
General Hospital · 208d
Cleared May 11, 1998
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
K973561
Medical Components, Inc.
General Hospital · 234d
Cleared Apr 28, 1998
I.V. CATHETER SYSTEM
K980493
Johnson & Johnson Medical, Inc.
General Hospital · 78d
Cleared Feb 26, 1998
INTROSYTE CATHETER
K974764
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 69d
Cleared Oct 17, 1997
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
K970864
Arrow Intl., Inc.
General Hospital · 221d
Cleared Sep 15, 1997
FIRST PICC CATHETER
K972262
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 90d
Cleared Sep 15, 1997
FIRST PICC CATHETER WITH DUAL LUMENS
K972263
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 90d
Cleared Sep 15, 1997
FIRST MIDCATH CATHETER
K972264
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 90d
Cleared Sep 12, 1997
FIRST MIDCATH CATHETER
K972254
Becton Dickinson Infusion Therapy Systems, Inc.
General Hospital · 88d