The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Flexstent Biliary Self Expanding Stent System; S.m.a.r.t. Re-flex Biliary Elf-expanding Stent System.
| Device ID | K130981 |
| 510k Number | K130981 |
| Device Name: | FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 6500 PASEO PADRE PARKWAY Fremont, CA 94555 |
| Contact | Kim Fonda |
| Correspondent | Kim Fonda CORDIS CORP. 6500 PASEO PADRE PARKWAY Fremont, CA 94555 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-09 |
| Decision Date | 2014-03-12 |