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
241–264 of 508
Cleared May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS
K981382
Catheter Innovations, Inc.
General Hospital · 15d
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 Feb 10, 1998
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER
K974543
Luther Medical Products, Inc.
General Hospital · 69d
Cleared Dec 24, 1997
INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
K971339
Becton Dickinson Vascular Access, Inc.
General Hospital · 258d
Cleared Nov 07, 1997
GESCO PER-Q-CATH PICC CATHETERS
K971990
Bard Access Systems, Inc.
General Hospital · 182d
Cleared Nov 07, 1997
GESCO PER-Q-CATH MIDLINE CATHETERS
K971991
Bard Access Systems, Inc.
General Hospital · 182d
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
Cleared Sep 09, 1997
VYGON UMBILICAL CATHETHER INSERTION TRAY
K963196
Vygon Corp.
General Hospital · 390d
Cleared Aug 21, 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
K962577
Arrow Intl., Inc.
General Hospital · 416d
Cleared Aug 01, 1997
AEROQUIP SAFESTART IV CATHETER
K970669
Aeroquip Medical Products
General Hospital · 158d
Cleared Jul 31, 1997
AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM
K970644
Aeroquip Medical Products
General Hospital · 161d
Cleared Apr 24, 1997
SAFE-CATH
K960764
Scientific Device Manufacturer, LLC
General Hospital · 423d
Cleared Mar 05, 1997
V-CATH
K964966
Hdc Corp.
General Hospital · 84d
Cleared Feb 10, 1997
CVP POLYURETHANE CATHETER
K961552
Abbott Laboratories
General Hospital · 294d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER KIT
K964048
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER WITH DUAL LUMENS
K964049
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER
K964050
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Dec 23, 1996
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
K962226
Johnson & Johnson Medical, Inc.
General Hospital · 196d
Cleared Nov 26, 1996
DISPOSABLE SCALP VEIN INFUSION SET
K953252
Myco Medical Supplies, Inc.
General Hospital · 503d