Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K971673 |
Device Name |
40 CC SUMO |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
LEO BASTA |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
LEO BASTA |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 05/07/1997 |
Decision Date | 08/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|