DXE · Class II · 21 CFR 870.5150

FDA Product Code DXE: Catheter, Embolectomy

Leading manufacturers include Shiley, Inc., Cathlab Corp. and Vascutech, Inc..

74
Total
74
Cleared
148d
Avg days
1976
Since
74 devices
49–72 of 74
Cleared Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625
Baxter Healthcare Corp
Cardiovascular · 88d
Cleared Mar 14, 1990
3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
K897184
Cathlab Corp.
Cardiovascular · 76d
Cleared Dec 07, 1989
CATHETER, CARDIOVASCULAR, BALLOON TYPE
K883852
Wb Intl., Inc.
Cardiovascular · 450d
Cleared Oct 12, 1989
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681
Shiley, Inc.
Cardiovascular · 79d
Cleared Sep 18, 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
K891021
Ideal Medical, Inc.
Cardiovascular · 202d
Cleared Aug 01, 1989
SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
K893680
Cathlab Corp.
Cardiovascular · 77d
Cleared Jul 20, 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410
Baxter Healthcare Corp
Cardiovascular · 104d
Cleared Jun 15, 1988
EMBOLECTOMY CATHETER(MODIFIED)
K881455
Cathlab Corp.
Cardiovascular · 70d
Cleared Aug 12, 1987
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
K872485
Ideas For Medicine, Inc.
Cardiovascular · 51d
Cleared Jan 06, 1987
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
K864062
Ideas For Medicine, Inc.
Cardiovascular · 78d
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 Jan 15, 1986
NOVA ARTERIAL EMBOLECTOMY CATHETER
K853625
Nova Medical Specialties
Cardiovascular · 139d
Cleared Jun 19, 1985
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
K850015
Polymed Laboratories
Cardiovascular · 168d
Cleared Aug 03, 1984
ARTERIAL EMBOLECTOMY CATHETER
K840198
Shiley, Inc.
Cardiovascular · 198d
Cleared Sep 29, 1983
SHILEY MULTIPRO CATHETER
K832044
Shiley, Inc.
Cardiovascular · 97d
Cleared Aug 31, 1983
EMBOLECTOMY CATHETER
K832023
Bionomy, Inc.
Cardiovascular · 79d
Cleared Mar 25, 1982
ATRAC TM MULTIPURPOSE BALLOON CATHETER
K820646
Atrium Medical Corp.
Cardiovascular · 16d
Cleared Oct 02, 1981
URE SIL EMBOLECTOMY/THROMBECTOMY CATH
K812640
Uresil Corp.
Cardiovascular · 16d
Cleared Aug 04, 1980
DESERET EMBOLECTOMY/THROMBECTOMY CATH.
K801650
Deseret Medical, Inc.
Cardiovascular · 17d
Cleared Jun 11, 1979
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
K790838
Shiley, Inc.
Cardiovascular · 41d
Cleared May 26, 1978
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K780762
Shiley, Inc.
Cardiovascular · 18d
Cleared Apr 13, 1978
CATHETERS, ARTERIAL EMBOLECTOMY
K780244
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 59d
Cleared Apr 27, 1977
CATHETER, ARTERIAL EMBOLECTOMY
K770714
Mallinckrodt Critical Care
Cardiovascular · 9d