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Medtronic Model 5013 Permanent Pacemaker Electrode

by Medtronic Vascular

510(k) K863536

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 NumberK863536 Date6 Jan 1987ClearedStatusActive

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  • Withdrawn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 5013
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 5013 is a transvenous ventricular pacing lead, a type of permanent pacemaker electrode used to deliver electrical stimulation to the heart’s ventricles. It is classified as a Permanent Pacemaker Electrode (product code DTB) and is intended for implantation within the cardiovascular system to support cardiac rhythm management.

This device is supplied sterile and designed for single-use implantation via the venous system. It is regulated under FDA 510(k) clearance (K863536) and falls under Class III medical device classification. Storage and handling must comply with sterile medical device protocols, and its use is restricted to qualified healthcare professionals in clinical settings.

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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 primary purpose of the Medtronic Model 5013 and how is it implanted in the body?

    The Medtronic Model 5013 is a transvenous ventricular pacing lead designed to deliver electrical stimulation to the heart’s ventricles for cardiac rhythm management. It is implanted via the venous system, meaning it is inserted through a vein (typically near the shoulder or neck) and threaded into the heart under sterile conditions by a qualified healthcare professional.

  • Is the Medtronic Model 5013 intended for reuse or is it meant to be used only once?

    The Medtronic Model 5013 is explicitly designed for single-use implantation. It is supplied sterile and should not be reused after one procedure to maintain safety and sterility standards.

  • How should the Medtronic Model 5013 be stored to ensure it remains sterile and functional?

    Since the Medtronic Model 5013 is sterile upon packaging, it must be stored according to sterile medical device protocols. This includes keeping it in its original, unopened packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures until ready for use.

  • What regulatory pathway does the Medtronic Model 5013 follow, and who oversees its approval?

    The Medtronic Model 5013 is regulated under the FDA 510(k) clearance process (with clearance number K863536) and is classified as a Class III medical device. Its regulatory submission was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee in 1987, and it is intended for use only by qualified healthcare professionals in clinical settings.