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Fibernet Embolic Protection System

by Lumen Biomedical, Inc.

510(k) K082348

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082348 Date18 Nov 2008ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1304-2014 FDA Class II initiated 3 Mar 2014
    • Terminated Z-1303-2014 FDA Class II initiated 3 Mar 2014

    Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NTE
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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