Device Classification Name |
catheter, percutaneous, cutting/scoring
|
510(k) Number |
K040155 |
Device Name |
PERIPHERAL CUTTING BALLOON |
Applicant |
BOSTON SCIENTIFIC CORP. |
3574 RUFFIN ROAD |
SAN DIEGO,
CA
92123
|
|
Applicant Contact |
RENUKA KRISHNAN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
3574 RUFFIN ROAD |
SAN DIEGO,
CA
92123
|
|
Correspondent Contact |
RENUKA KRISHNAN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/23/2004 |
Decision Date | 07/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|