Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K001338 |
FOIA Releasable 510(k) |
K001338
|
Device Name |
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Applicant Contact |
ABBY LIPMAN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Correspondent Contact |
ABBY LIPMAN |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/27/2000 |
Decision Date | 08/30/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|