Device Classification Name |
Catheter, Ureteral, Gastro-Urology
|
510(k) Number |
K133750 |
Device Name |
OCCLUDER OCCLUSION BALLOON CATHETER |
Applicant |
Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
CHRISTINE SHOEMAKER |
Correspondent |
Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
CHRISTINE SHOEMAKER |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 12/09/2013 |
Decision Date | 01/08/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|