GBX · Class I · 21 CFR 878.4200

FDA Product Code GBX: Catheter, Irrigation

Leading manufacturers include Sil-Med Corp., Navarre Biomedical , Ltd. and Mikro-Tek Laboratories.

77
Total
77
Cleared
122d
Avg days
1977
Since
77 devices
49–72 of 77
Cleared Jan 21, 1992
THORACIC CATHETER WITH GUIDE
K913542
Intl. Medical Devices , Ltd.
General & Plastic Surgery · 165d
Cleared Apr 22, 1991
I/A HANDPIECE WITH REPLACEABLE TIPS
K910245
Surgical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Mar 20, 1991
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614
Baxter Healthcare Corp
General & Plastic Surgery · 96d
Cleared Mar 06, 1991
DRAINAGE TUBE RESTRAINT/WOUND COVER
K905766
M. Imonti and Associates Inc.,
General & Plastic Surgery · 69d
Cleared Feb 11, 1991
PVC ROUND WOUND DRAINS
K905422
Axiom Medical, Inc.
General & Plastic Surgery · 69d
Cleared Oct 11, 1990
DISPOSABLE FLUID COLLECTION BAG
K904133
Axiom Medical, Inc.
General & Plastic Surgery · 35d
Cleared Dec 27, 1989
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516
Arrow Intl., Inc.
General & Plastic Surgery · 106d
Cleared Dec 27, 1989
MIKRO-LAVAGE-1
K895755
Mikro-Tek Laboratories
General & Plastic Surgery · 92d
Cleared Dec 27, 1989
MIKRO-AQUAPURATOR
K895756
Mikro-Tek Laboratories
General & Plastic Surgery · 92d
Cleared Oct 19, 1989
IRRI-EVACUATOR
K895757
Mikro-Tek Laboratories
General & Plastic Surgery · 23d
Cleared Sep 13, 1988
THORACIC CATHETERS
K883474
Westmark, Sterile Packing Systems, Inc. (Sps)
General & Plastic Surgery · 28d
Cleared Mar 27, 1987
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 35d
Cleared Jun 27, 1985
CONTINUOUS VENTILATOR
K844809
Hamilton Medical, Inc.
General & Plastic Surgery · 182d
Cleared Jun 26, 1985
HALL IRRIGATION SYSTEM
K852143
Hall Surgical, Division of Zimmer, Inc.
General & Plastic Surgery · 41d
Cleared Jun 05, 1985
PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,
K844876
Pennine Medical , Ltd.
General & Plastic Surgery · 170d
Cleared May 21, 1985
MICROTEK IRRIGATION SYSTEM
K844061
Microtek Medical, Inc.
General & Plastic Surgery · 215d
Cleared May 03, 1985
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475
Vygon Corp.
General & Plastic Surgery · 18d
Cleared Mar 18, 1985
PERIMETER THORACIC CATHETER
K844922
Perimeter Medical, Inc.
General & Plastic Surgery · 89d
Cleared Nov 29, 1984
PRUITT IRRIGATION AND OCCLUSION CATHETER
K844094
Bionomy, Inc.
General & Plastic Surgery · 42d
Cleared Oct 24, 1984
SDC SILICONE SUMP DRAIN
K843617
Science Development Corp.
General & Plastic Surgery · 40d
Cleared Aug 02, 1984
TIDAL DISTENSION IRRIGATION SET
K841362
Abbott Laboratories
General & Plastic Surgery · 122d
Cleared Apr 25, 1984
SILICONE SUCTION & IRRIGATION DRAIN
K840323
Superior Plastic Products Corp.
General & Plastic Surgery · 91d
Cleared May 02, 1983
I/A KIT
K830859
Surgeon Surgical Instrumentation, Inc.
General & Plastic Surgery · 46d
Cleared Dec 28, 1982
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496
Travenol Laboratories, S.A.
General & Plastic Surgery · 35d