| Device Classification Name |
catheter, biliary, diagnostic
|
|---|
| 510(K) Number |
K122072 |
|---|
| Device Name |
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE |
|---|
| Applicant |
| BOSTON SCIENTIFIC CORPORATION |
| 100 boston scientific way |
|
marlborough,
MA
01752
|
|
| Contact |
laurie pannella |
| Regulation Number | 876.5010
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/16/2012 |
|---|
| Decision Date | 09/28/2012 |
|---|
| Decision |
substantially equivalent - with limitations (SU) |
|---|
| Classification Advisory Committee |
Gastroenterology/Urology
|
|---|
| Review Advisory Committee |
Gastroenterology/Urology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
