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Attain Hybrid Guide Wire

by Medtronic, Inc.

510(k) K143316

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)SESE Substantially Equivalent · Traditional NumberK143316 Date11 Mar 2015ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA product code
DQX
Device class
Class II
Regulation
21 CFR Part 870.1330
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Attain Hybrid Guide Wire is a cardiovascular device intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature. It is designed to navigate vein branches during cardiac procedures. The device functions as a guide wire to facilitate lead positioning.

The Attain Hybrid Guide Wire is supplied by Medtronic, Inc. and is used in clinical settings for transvenous lead placement. It is available in models Gwr419378, Gwr419388, Gwr419478, Gwr419588, and Gwr419688. The device is subject to FDA 510(k) authorization under product code DQX and was cleared as substantially equivalent. Storage and sterility details are not specified in the provided data.

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the Attain Hybrid Guide Wire used for?

    The Attain Hybrid Guide Wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature by navigating vein branches during cardiac procedures to facilitate lead positioning.

  • How is the Attain Hybrid Guide Wire supplied and what models are available?

    The Attain Hybrid Guide Wire is supplied by Medtronic, Inc. and is available in models Gwr419378, Gwr419388, Gwr419478, Gwr419588, and Gwr419688 for clinical use in transvenous lead placement procedures.

  • Is the Attain Hybrid Guide Wire sterile and intended for single use?

    The provided data does not specify sterility or single-use status for the Attain Hybrid Guide Wire, so no conclusion can be drawn about its sterility or reuse characteristics from the given information.

  • What regulatory pathway was used for the Attain Hybrid Guide Wire?

    The Attain Hybrid Guide Wire received FDA 510(k) authorization under product code DQX and was cleared as substantially equivalent through a traditional review process.