Device Classification Name |
Prosthesis, Esophageal
|
510(k) Number |
K012883 |
Device Name |
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Applicant Contact |
KATHLEEN MORAHAN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Correspondent Contact |
KATHLEEN MORAHAN |
Regulation Number | 878.3610
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/28/2001 |
Decision Date | 10/12/2001 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|