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Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488

by Medtronic Inc. Cardiac Rhythm Management

510(k) K063210

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 NumberK063210 Date15 Mar 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0265-2014 FDA Class I initiated 21 Oct 2013

    Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

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  • Withdrawn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
DQX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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