DXE · Class II · 21 CFR 870.5150

FDA Product Code DXE: Catheter, Embolectomy

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

74
Total
74
Cleared
148d
Avg days
1976
Since
74 devices
49–72 of 74
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
Cleared Apr 05, 1977
CATHETER, EMBOLECTOMY, UMI
K770569
Universal Medical Instrument Corp.
Cardiovascular · 11d
Cleared Dec 13, 1976
ELECATH ARTERIAL EMBOLECTOMY CATHETER
K761031
Electro-Catheter Corp.
Cardiovascular · 28d