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Medtronic Model 5062 Permanent Pacemaker Electrode

by Medtronic Vascular

510(k) K853398

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 NumberK853398 Date4 Dec 1985ClearedStatusActive

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  • Withdrawn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 5062
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 Model 5062 is a Permanent Pacemaker Electrode, a Class III medical device designed for implantation in the cardiovascular system. It is intended to deliver electrical impulses to the heart, facilitating proper cardiac rhythm regulation in patients requiring chronic pacing support.

This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in a clinical setting. Authorized under FDA 510(k) clearance (K853398) with a traditional review pathway, it adheres to regulatory standards for Class III devices (product code DTB). No additional MRI safety or reusable specifications are noted in the data.

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 Medtronic Model 5062 used for in clinical practice?

    The Medtronic Model 5062 is a Permanent Pacemaker Electrode designed to deliver electrical impulses to the heart, helping maintain proper cardiac rhythm in patients who require long-term pacing support. It is specifically intended for implantation in the cardiovascular system by qualified healthcare professionals to assist patients with chronic pacing needs.

  • Is the Medtronic Model 5062 intended for single-use or reusable applications?

    The Medtronic Model 5062 is supplied sterile and explicitly intended for single-use implantation only. It is not designed for reuse, ensuring patient safety and compliance with medical device standards for permanent pacemaker electrodes.

  • What regulatory pathway was followed for FDA clearance of the Medtronic Model 5062?

    The Medtronic Model 5062 received FDA clearance through the 510(k) traditional review pathway under the product code DTB, which categorizes it as a Class III device. The clearance number is K853398, and it was determined to be substantially equivalent to a predicate device, adhering to strict regulatory standards for cardiovascular implants.

  • How should the Medtronic Model 5062 be stored before use?

    While specific storage instructions are not detailed in the provided data, the device is supplied sterile and must be handled in accordance with standard medical device protocols to maintain sterility. It should be stored in a clean, dry environment, protected from contamination, and used only in a clinical setting by trained professionals.

  • Does the Medtronic Model 5062 have any special considerations for MRI compatibility?

    The provided data does not mention any MRI safety specifications for the Medtronic Model 5062. If MRI exposure is required for the patient, clinicians should consult Medtronic’s official guidelines or device labeling to assess potential risks, as pacemaker electrodes may interact with magnetic fields.