Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K952063 |
Device Name |
XXL BALLON DILATATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
MARY P LEGRAY |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
MARY P LEGRAY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/02/1995 |
Decision Date | 11/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|