The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Lifestent Flexstart Biliary Stent System.
| Device ID | K053404 |
| 510k Number | K053404 |
| Device Name: | LIFESTENT FLEXSTART BILIARY STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Kevin Drisko |
| Correspondent | Kevin Drisko EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-07 |
| Decision Date | 2005-12-21 |
| Summary: | summary |