The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Lifestent Biliary Stent System, Lifestent Xl Biliary Stent System.
| Device ID | K130792 |
| 510k Number | K130792 |
| Device Name: | LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Contact | Christoph Wagner Von Hoff |
| Correspondent | Christoph Wagner Von Hoff C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-22 |
| Decision Date | 2013-08-30 |
| Summary: | summary |