Ave Bridge Stent System

FDA 510(k) K971295 · Arterial Vascular Engineering, Inc.

Substantially Equivalent

510(k) numberK971295

Submission

Device name
Ave Bridge Stent System
Applicant
Arterial Vascular Engineering, Inc.
Santa Rosa, CA, US
Received
April 7, 1997
Decision date
November 5, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FGE – Stents, Drains And Dilators For The Biliary Ducts
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5010
Specialty
Gastroenterology, Urology
Implant
Yes
Life-sustaining
Yes

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K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional Olympus Medical Systems Corporation10/21/2025SE
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More from Softac Medical Technologies

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Questions and answers

When was Ave Bridge Stent System cleared by the FDA?

Ave Bridge Stent System (K971295) received a 510(k) decision of Substantially Equivalent on November 5, 1997, 212 days after the submission was received.

What is the product code of K971295?

The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.