Device Classification Name |
Catheter, Embolectomy
|
510(k) Number |
K901627 |
Device Name |
ARTERIAL EMBOLECTOMY CATHETER |
Applicant |
APPLIED VASCULAR DEVICES, INC. |
26051 MERIT CIRCLE, #104 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
ROBERT P COOPER |
Correspondent |
APPLIED VASCULAR DEVICES, INC. |
26051 MERIT CIRCLE, #104 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
ROBERT P COOPER |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 04/09/1990 |
Decision Date | 10/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|