DXE · Class II · 21 CFR 870.5150

FDA Product Code DXE: Catheter, Embolectomy

Leading manufacturers include Shiley, Inc., Applied Medical Resources and Atrium Medical Corp..

74
Total
74
Cleared
148d
Avg days
1976
Since
74 devices
25–48 of 74
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
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 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