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Medtronic AVE Stent Delivery System for Biliary Indication

by Peripheral Ave

510(k) K991533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK991533 Date29 Jul 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Medtronic Ave Stent Delivery System - for Use in Biliary Indication
510(k) Number
FDA Product Code
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESU

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medtronic AVE Stent Delivery System is a device intended to maintain patency of a biliary duct that is occluded by a malignant tumor. It is classified as Stents, Drains and Dilators for the Biliary Ducts.

The device is supplied sterile and is intended for single use. It is regulated as a Class II medical device subject to special controls. The device is not indicated for use in the biliary ducts.

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