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 |