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Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T

by Medtronic Perfusion Systems

510(k) K013084

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013084 Date27 Sep 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
DTM
Device Class
Class II
Regulation
21 CFR Part 870.4260
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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