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Unipolar Lead Configuration Conductor

by Daig Corp. 510(k)

Active United States

510(k) K800348

Overview

This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It serves as a unipolar lead configuration conductor, facilitating electrical signal transmission between a pacemaker and the heart to regulate cardiac rhythm in patients requiring permanent pacing support.

The Unipolar Lead Configuration Conductor is designed for single-use implantation in the cardiovascular setting, adhering to strict sterility standards. Supplied as a sterile, pre-terminated lead, it is intended for use with compatible pacemaker systems and must be implanted by trained healthcare professionals. Regulated under FDA 510(k) clearance (K800348), it complies with 21 CFR 870.3680 for permanent pacemaker electrodes, with no third-party involvement in its distribution.

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 NumberK800348 Date28 May 1980ClearedStatusActive

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

  • Is this device intended for reuse or is it designed for single-use only after implantation?

    This unipolar lead configuration conductor is explicitly designed for single-use implantation only. It is supplied sterile and pre-terminated, meaning it is intended to be used once in a patient and then discarded. Reuse is not supported or recommended due to sterility and safety concerns for the patient.

  • What types of pacemaker systems is this lead compatible with, and how is it supplied?

    This unipolar lead configuration conductor is designed for use with compatible pacemaker systems that support unipolar lead configurations. It is supplied as a sterile, pre-terminated lead, ready for direct implantation by trained healthcare professionals. No additional preparation or assembly is required beyond sterile handling.

  • How should this device be stored before use, and what sterility standards does it meet?

    The device must be stored in its original, unopened packaging to maintain sterility, as it is supplied sterile for single-use. The manufacturer adheres to strict sterility standards to ensure it remains uncontaminated until implantation. Always follow the included instructions for storage conditions.

  • What regulatory pathway was followed for this device’s approval, and how is it classified?

    This unipolar lead configuration conductor is classified as a Class III medical device under FDA regulations and was cleared through the 510(k) pathway (K800348). It is determined to be substantially equivalent to a predicate device and complies with 21 CFR 870.3680, which governs permanent pacemaker electrodes. The clearance was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee.