Device Classification Name |
clamp, vascular
|
510(k) Number |
K964161 |
Device Name |
HEARTPORT ENDOAORTIC CLAMP |
Applicant |
HEARTPORT, INC. |
200 CHESAPEAKE DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
KEVIN F MACDONALD |
Correspondent |
HEARTPORT, INC. |
200 CHESAPEAKE DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
KEVIN F MACDONALD |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 10/17/1996 |
Decision Date | 04/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|