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Lead, Timed Pacing, Implantable

by Daig Corp. 510(k)

Active United States

510(k) K782004

Overview

This device is an implantable timed pacing lead, classified as a permanent pacemaker electrode. It is designed to deliver electrical stimulation to the heart to regulate cardiac rhythm in patients with bradycardia or conduction disorders, ensuring proper pacing signals are delivered at precise intervals.

The lead is intended for surgical implantation within the cardiovascular system, typically affixed to the heart muscle or within the cardiac chambers. Supplied sterile for single-use, it adheres to FDA 510(k) clearance (K782004) under the traditional review pathway. Compliance with regulatory standards ensures safe use in clinical settings, with no noted MRI compatibility restrictions in the submitted data.

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 NumberK782004 Date15 Dec 1978ClearedStatusActive

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 primary purpose of this implantable timed pacing lead, and how does it function in the body?

    This lead is designed to deliver timed electrical stimulation to the heart, helping regulate cardiac rhythm in patients with bradycardia or conduction disorders. It ensures precise pacing signals are provided to maintain proper heart function by stimulating the heart muscle or chambers where it is surgically implanted.

  • Is this device intended for single-use or can it be reused after implantation?

    The device is supplied sterile for single-use only. Once implanted, it is not intended for removal or reuse, adhering to standard medical practice for implantable pacing leads.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

    This lead received FDA clearance under the traditional review pathway (510(k) clearance, K782004) and was determined to be substantially equivalent to a predicate device. This means it meets regulatory standards for safety and effectiveness as evaluated by the FDA, ensuring it can be legally marketed and used in clinical settings for its intended purpose.

  • Are there any special handling or storage requirements for this lead before implantation?

    Since the lead is supplied sterile for single-use, it must be stored in its original packaging to maintain sterility until implantation. Proper handling, including avoiding contamination or exposure to moisture, is critical to ensure the device remains safe for surgical use.

  • What types of patients or clinical scenarios is this lead typically used for?

    This lead is intended for patients with bradycardia (slow heart rate) or conduction disorders where electrical pacing is required to maintain proper heart rhythm. It is surgically implanted within the cardiovascular system to deliver timed pacing signals, ensuring reliable cardiac function in these conditions.