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Explorer Permanent Pacemaker Electrode

by Mansfield Scientific, Inc.

510(k) K853850

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 NumberK853850 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  • Withdrawn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
Explorer
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 Explorer is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed for implantation within the cardiovascular system to facilitate cardiac pacing, ensuring proper electrical stimulation of the heart to maintain normal rhythm and function in patients with bradycardia or other conduction disorders.

This device is supplied sterile and intended for single-use implantation. It is regulated under FDA 510(k) clearance (K853850) and adheres to the Permanent Pacemaker Electrode nomenclature (DTB product code). The electrode is intended for use in sterile surgical environments and must be handled with aseptic techniques to prevent infection. No MRI safety information is specified, and storage conditions are not detailed in the provided data.

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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 Explorer device used for in clinical practice?

    The Explorer is a permanent pacemaker electrode designed for implantation within the cardiovascular system to deliver electrical stimulation to the heart. It helps maintain normal heart rhythm and function in patients with bradycardia or conduction disorders, ensuring consistent pacing when the heart’s natural electrical signals are insufficient.

  • Is the Explorer device intended for reuse, or is it meant to be used only once?

    The Explorer is sterile and intended for single-use implantation only. Due to its sterile packaging and surgical application, reuse is not recommended to prevent infection or compromise performance.

  • What regulatory pathway does the Explorer follow, and how was it cleared?

    The Explorer was cleared through the FDA 510(k) process under the Traditional Review pathway, with a decision date of December 4, 1985. It is classified as a Class III medical device and was determined to be substantially equivalent to a predicate device, as reviewed by the Cardiovascular (CV) Advisory Committee.

  • Are there specific storage instructions provided for the Explorer?

    The provided data does not specify storage conditions for the Explorer. However, as a sterile, single-use device intended for surgical implantation, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.

  • What types of patients or clinical scenarios would benefit most from using the Explorer?

    The Explorer is primarily intended for patients requiring chronic cardiac pacing due to conditions like bradycardia, heart block, or other conduction abnormalities. It is used in procedures where a permanent pacemaker system is implanted to regulate heart rhythm long-term, particularly in cases where the patient’s natural pacemaker is insufficient.