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Medtronic Model 6957 Permanent Pacemaker Electrode

by Medtronic Vascular 2 variants

510(k) K791769

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 NumberK791769 Date19 Sep 1979ClearedStatusActive

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  • Withdrawn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 Model 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, 20 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 Model 6957 is a Permanent Pacemaker Electrode, classified under product code DTB. This unipolar screw-in lead is designed to facilitate cardiac pacing by delivering electrical impulses to the heart muscle, ensuring proper heart rhythm regulation in patients requiring long-term pacing support.

Intended for single-use implantation, the device is supplied sterile and requires surgical placement within the cardiovascular system. It is regulated under FDA 510(k) clearance (K791769/K790429) as a Class III device, adhering to strict medical device standards. No additional context on MRI safety, reusable status, or alternative sizes is provided in the available data.

Other devices from Medtronic Vascular, Inc.

See all devices from Medtronic Vascular, Inc. →

Questions

AI-generated answers, 20 Sep 2026

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

  • Is the Medtronic Model 6957 designed for reuse after a single implantation, or is it intended for single-use only?

    The Medtronic Model 6957 is explicitly intended for single-use implantation only. The device is supplied sterile and is not designed or approved for reuse, ensuring patient safety and sterility standards are maintained during surgical procedures.

  • What types of patients is this pacemaker electrode typically used for, and how is it implanted?

    This device is designed for patients requiring long-term cardiac pacing support, such as those with bradycardia or other rhythm disorders. It is a unipolar screw-in lead that must be surgically implanted within the cardiovascular system by a trained clinician. The screw-in mechanism allows secure fixation in the heart tissue.

  • How is the Medtronic Model 6957 regulated, and what does its FDA clearance status mean for clinicians?

    The Medtronic Model 6957 is classified as a Class III device under FDA regulations and holds 510(k) clearance (K791769/K790429). This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for its intended use in permanent pacemaker applications.

  • Are there different sizes or models available for the Medtronic Model 6957, or is it a single standardized design?

    The provided data does not specify alternative sizes or models for the Medtronic Model 6957. It is described as a single standardized unipolar screw-in lead, meaning it is likely offered in one primary configuration for general use in permanent pacemaker systems.