Device Classification Name |
Catheter, Percutaneous, Cutting/Scoring
|
510(k) Number |
K041993 |
Device Name |
2 CM PERIPHERAL CUTTING BALOON |
Applicant |
BOSTON SCIENTIFIC IVT |
3574 RUFFIN RD. |
SAN DIEGO,
CA
92123 -3597
|
|
Applicant Contact |
RENUKA KRISHNAN |
Correspondent |
BOSTON SCIENTIFIC IVT |
3574 RUFFIN RD. |
SAN DIEGO,
CA
92123 -3597
|
|
Correspondent Contact |
RENUKA KRISHNAN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/23/2004 |
Decision Date | 08/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|