The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Wallstent Rp Endoprosthesis Transhepatic Biliary, Wallstent Endoprosthesis Transhepatic Biliary.
| Device ID | K152853 |
| 510k Number | K152853 |
| Device Name: | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Carah Kucharski |
| Correspondent | Carah Kucharski BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2015-11-20 |
| Summary: | summary |