Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K150303 |
Device Name |
XXL Vascular Balloon Dilatation Catheter |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
Melanie Raska |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
Melanie Raska |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/06/2015 |
Decision Date | 06/15/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|