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Achieve Mapping Catheter and Electrical Cable

by Medtronic Ablation Frontiers, LLC

510(k) K102588

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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)SESE Substantially Equivalent · Traditional NumberK102588 Date18 Mar 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0200-2016 FDA Class II initiated 29 Sep 2015

    64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

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  • Withdrawn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
DRF
Device Class
Class II
Regulation
21 CFR Part 870.1220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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