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Endocard. Pacin/ Lead-Long Length PL200

by Daig Corp. 510(k)

Active United States

510(k) K771565

Overview

This device is a Permanent Pacemaker Electrode, designed for implantation within the heart to facilitate cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring proper cardiac function through sustained, low-energy stimulation.

The Endocard Pacin/Lead-Long Length PL200 is intended for single-use implantation in cardiac electrophysiology procedures. Supplied sterile and packaged for surgical use, it adheres to FDA 510(k) clearance under the Traditional pathway, classified as a Class III device (DTB product code). Compliance with regulation 870.3680 ensures adherence to cardiovascular device standards, with no MRI safety restrictions specified.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771565 Date14 Sep 1977ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Endocard Pacin/Lead-Long Length PL200 used for in clinical practice?

    This device is a permanent pacemaker electrode designed to be implanted inside the heart to deliver controlled electrical impulses. It helps regulate heart rhythm in patients with bradycardia or conduction disorders by providing sustained, low-energy stimulation to maintain proper cardiac function during daily activities.

  • Is the Endocard Pacin/Lead-Long Length PL200 intended for reuse or single-use?

    The device is explicitly intended for single-use implantation in cardiac electrophysiology procedures. It is supplied sterile and packaged for surgical use, ensuring safety and sterility for one-time clinical application.

  • How is the regulatory pathway for this device classified, and what does that mean for its use?

    The Endocard Pacin/Lead-Long Length PL200 is classified as a Class III device under the FDA’s Traditional 510(k) pathway, meaning it undergoes rigorous review for safety and effectiveness. It was cleared as substantially equivalent to a predicate device, ensuring compliance with cardiovascular device standards (regulation 870.3680) for reliable cardiac pacing applications.

  • Are there any restrictions on using this device with MRI equipment?

    The device data does not specify any MRI safety restrictions, meaning there is no explicit warning or guidance about its compatibility with MRI procedures. However, clinicians should always verify compatibility with their specific MRI system and follow manufacturer guidelines to avoid potential risks.