DXE · Class II · 21 CFR 870.5150

FDA Product Code DXE: Catheter, Embolectomy

Leading manufacturers include Shiley, Inc., Vascutech, Inc. and Lucas Medical, Inc..

74
Total
74
Cleared
148d
Avg days
1976
Since
74 devices
25–48 of 74
Cleared Feb 13, 1998
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K974335
J-Lloyd Medical, Inc.
Cardiovascular · 87d
Cleared Jan 13, 1998
SINGLE LUMEN EMBOLECTOMY CATHETER
K972572
American Biomed, Inc.
Cardiovascular · 187d
Cleared Nov 19, 1997
LMI IRRIGATION CATHETER (IGR)
K972623
Lucas Medical, Inc.
Cardiovascular · 128d
Cleared Jul 01, 1997
LMI THROMBECTOMY CATHETER
K970657
Lucas Medical, Inc.
Cardiovascular · 130d
Cleared Mar 28, 1997
DUAL LUMEN EMBOLECTOMY CATHETER
K970762
Applied Medical Resources
Cardiovascular · 25d
Cleared Jan 13, 1997
VERSA-CATH ARTERIAL CATHETER
K961883
Ideas For Medicine, Inc.
Cardiovascular · 243d
Cleared Dec 27, 1996
NEEDLE'S EYE SNARE
K961992
Cook Pacemaker Corp.
Cardiovascular · 220d
Cleared Sep 19, 1996
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
K961716
Ideas For Medicine, Inc.
Cardiovascular · 140d
Cleared Apr 11, 1996
LMI ARTERIAL EMBOLECTOMY CATHETER
K954760
Lucas Medical, Inc.
Cardiovascular · 177d
Cleared Mar 11, 1996
LMI OCCLUSION CATHETER
K955125
Lucas Medical, Inc.
Cardiovascular · 123d
Cleared May 15, 1995
AVD INTIMAX THROMBECTOMY CATHETER
K950586
Applied Medical Resources
Cardiovascular · 95d
Cleared Jul 25, 1994
ARTERIAL EMBOLECTOMY
K935405
J-Lloyd Medical, Inc.
Cardiovascular · 258d
Cleared Mar 04, 1993
WELTER SNARE RETRIEVER
K920823
Cook, Inc.
Cardiovascular · 374d
Cleared Apr 26, 1991
INTIMAX THROMBECTOMY CATHETER
K910372
Applied Vascular Devices, Inc.
Cardiovascular · 87d
Cleared Dec 03, 1990
AMPLATZ GOOSE-NECK SNARE
K901502
Microvena Corp.
Cardiovascular · 249d
Cleared Oct 19, 1990
ARTERIAL EMBOLECTOMY CATHETER
K901627
Applied Vascular Devices, Inc.
Cardiovascular · 193d
Cleared Jul 17, 1990
ARTERIAL EMBOLECTOMY CATHETER
K900311
Impra, Inc.
Cardiovascular · 176d
Cleared Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625
Baxter Healthcare Corp
Cardiovascular · 88d
Cleared Oct 12, 1989
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681
Shiley, Inc.
Cardiovascular · 79d
Cleared Jul 20, 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410
Baxter Healthcare Corp
Cardiovascular · 104d
Cleared Jan 06, 1987
SHEAR FORCE GAUGE
K864330
American Edwards Laboratories
Cardiovascular · 63d
Cleared Jan 02, 1987
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007
Uresil Corp.
Cardiovascular · 79d
Cleared Aug 03, 1984
ARTERIAL EMBOLECTOMY CATHETER
K840198
Shiley, Inc.
Cardiovascular · 198d
Cleared Sep 29, 1983
SHILEY MULTIPRO CATHETER
K832044
Shiley, Inc.
Cardiovascular · 97d