AVE BRIDGE STENT SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

ARTERIAL VASCULAR ENGINEERING, INC.

The following data is part of a premarket notification filed by Arterial Vascular Engineering, Inc. with the FDA for Ave Bridge Stent System.

Pre-market Notification Details

Device IDK971295
510k NumberK971295
Device Name:AVE BRIDGE STENT SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant ARTERIAL VASCULAR ENGINEERING, INC. 3576 UNOCAL PL. Santa Rosa,  CA  95403
ContactPaul Meyer
CorrespondentPaul Meyer
ARTERIAL VASCULAR ENGINEERING, INC. 3576 UNOCAL PL. Santa Rosa,  CA  95403
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-07
Decision Date1997-11-05
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.