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Medtronic 6957 Permanent Pacemaker Electrode

by Medtronic Vascular

510(k) K843706

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 NumberK843706 Date27 Dec 1984ClearedStatusActive

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  • Withdrawn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)

Full name
Medtronic 6957
510(k) Number
FDA product code
DTB
Device class
Class III
Regulation
21 CFR Part 870.3680
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Medtronic 6957 is a Permanent Pacemaker Electrode, classified under product code DTB. This unipolar screw-in lead is designed for implantation in cardiac pacing applications, providing electrical stimulation to regulate heart rhythm in patients requiring chronic pacing support.

This device is intended for single-use implantation in sterile operating room settings, adhering to Class III regulatory standards. Supplied sterile and packaged for surgical use, it requires professional medical expertise for positioning within the heart’s right ventricle or atrium. Authorized under FDA 510(k) clearance (K843706), it is not MRI-compatible and must be handled with care to avoid damage. Storage follows manufacturer guidelines to maintain sterility and functionality.

Other devices from Medtronic Vascular, Inc.

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Questions

AI-generated answers, 18 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 intended use of the Medtronic 6957?

    The Medtronic 6957 is a permanent pacemaker electrode designed for cardiac pacing applications. It is a unipolar screw-in lead intended to provide electrical stimulation to regulate heart rhythm in patients who require chronic pacing support. It must be positioned within the patient's right ventricle or atrium by a medical professional.

  • Is the Medtronic 6957 suitable for reuse or MRI procedures?

    No, the device is strictly for single-use implantation and is not MRI-compatible. Because it is supplied sterile for surgical use, it must not be reused to ensure patient safety and maintain the integrity of the device. Additionally, the device is not compatible with MRI environments, so clinicians must avoid exposing the implanted lead to MRI procedures.

  • How is the Medtronic 6957 supplied and what are the storage requirements?

    The device is supplied sterile and packaged specifically for surgical use in a sterile operating room setting. To maintain its sterility and functionality, the device must be stored according to the manufacturer's guidelines. Proper storage is essential to ensure the lead remains safe and effective for its intended implantation procedure.

  • What is the regulatory status of the Medtronic 6957?

    The Medtronic 6957 is authorized under FDA 510(k) clearance, specifically identified by K-number K843706. It is classified as a Class III device under regulation number 870.3680. This clearance indicates that the device was reviewed and found to be substantially equivalent to existing devices for its intended use.