Device Classification Name |
prosthesis, tracheal, expandable
|
510(k) Number |
K152842 |
FOIA Releasable 510(k) |
K152842
|
Device Name |
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL |
Applicant |
BOSTON SCIENTIFIC CORPORATION |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
CARAH KUCHARSKI |
Correspondent |
BOSTON SCIENTIFIC CORPORATION |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
CARAH KUCHARSKI |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 09/29/2015 |
Decision Date | 05/19/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|