The following data is part of a premarket notification filed by Arterial Vascular Engineering, Inc. with the FDA for Ave Bridge Stent System.
| Device ID | K971295 |
| 510k Number | K971295 |
| Device Name: | AVE BRIDGE STENT SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ARTERIAL VASCULAR ENGINEERING, INC. 3576 UNOCAL PL. Santa Rosa, CA 95403 |
| Contact | Paul Meyer |
| Correspondent | Paul Meyer ARTERIAL VASCULAR ENGINEERING, INC. 3576 UNOCAL PL. Santa Rosa, CA 95403 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-11-05 |
| Summary: | summary |