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
193–216 of 507
Cleared Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
K992198
Cook, Inc.
General Hospital · 58d
Cleared Aug 20, 1999
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
K990236
Johnson & Johnson Medical, Div. of Ethicon, Inc.
General Hospital · 207d
Cleared Jun 16, 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
K991406
Terumo Medical Corp.
General Hospital · 55d
Cleared May 27, 1999
NORMAL SALINE FLUSH SYRINGE
K984614
Rocap Div. of Sabratek Corp.
General Hospital · 149d
Cleared May 05, 1999
ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
K984189
Maxxim Medical
General Hospital · 163d
Cleared Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
K984059
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 147d
Cleared Jan 29, 1999
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
K984055
Sims Deltec, Inc.
General Hospital · 77d
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 Nov 23, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
K983916
Hdc Corp.
General Hospital · 20d
Cleared Oct 16, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1
K983409
Hdc Corp.
General Hospital · 18d
Cleared Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566
Boston Scientific Corp
General Hospital · 213d
Cleared Aug 18, 1998
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291
K981905
Acu-Pak
General Hospital · 78d
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 May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS
K981368
Catheter Innovations, Inc.
General Hospital · 16d
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