Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K021721 |
Device Name |
EQUALIZER BALLOON CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Applicant Contact |
JENNIFER BOLTON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Correspondent Contact |
JENNIFER BOLTON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/24/2002 |
Decision Date | 06/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|