The following data is part of a premarket notification filed by Ostial Corporation with the FDA for Archstent Biliary System.
| Device ID | K113582 |
| 510k Number | K113582 |
| Device Name: | ARCHSTENT BILIARY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Contact | Kaitlin Von Hoffmann |
| Correspondent | Kaitlin Von Hoffmann OSTIAL CORPORATION 510 CLYDE AVENUE Mountain View, CA 94043 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-06-29 |
| Summary: | summary |