Device Classification Name |
pancreatic stent, covered, metallic, removable
|
510(k) Number |
K150692 |
FOIA Releasable 510(k) |
K150692
|
Device Name |
AXIOS Stent with Electrocautery Enhanced Delivery System |
Applicant |
BOSTON SCIENTIFIC CORP. |
453 Ravendale Drive, Suite H |
Mountain View,
CA
94043
|
|
Applicant Contact |
Carole Sykes |
Correspondent |
Boston Scientific Corp. |
453 RAVENDALE DRIVE, SUITE H |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
Carole Sykes |
Regulation Number | 876.5015
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/18/2015 |
Decision Date | 08/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02146352
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|