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Permanent Implant Endocardial Pacemaker Lead

by Daig Corp. 510(k)

Active United States

510(k) K770195

Overview

This device is a permanent implant endocardial pacemaker lead, classified under the nomenclature for cardiac pacing electrodes. It is designed for transvenous implantation within the heart to deliver electrical stimulation for pacing purposes, ensuring synchronized cardiac contractions in patients with bradycardia or conduction disorders.

The lead is intended for surgical implantation by a qualified physician in a sterile operating room environment. It is supplied as a single-use, sterile device and must be handled using aseptic techniques. Compliance with FDA 510(k) clearance (K770195) and regulation 870.3680 ensures adherence to safety and performance standards for cardiac pacing leads. No MRI safety information or reusable specifications are provided in the 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 NumberK770195 Date7 Feb 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)

Full name
Perm. Implant. Endocardial Pac. Lead
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 Daig Corp. permanent implant endocardial pacemaker lead, and how is it typically used in clinical practice?

    This device is designed to deliver electrical stimulation within the heart to maintain synchronized contractions in patients with bradycardia or conduction disorders. It is implanted transvenously by a qualified physician in a sterile operating room environment, ensuring reliable pacing support for long-term cardiac rhythm management.

  • Is this pacemaker lead intended for reuse, or is it meant for single-use only? How should it be handled during implantation?

    The lead is explicitly supplied as a single-use, sterile device. It must be handled using aseptic techniques to prevent contamination, as it is intended for surgical implantation in a sterile operating room environment.

  • What regulatory pathway does this device follow, and what does that mean for its safety and performance standards?

    This device follows the FDA 510(k) clearance pathway (K770195) under regulation 870.3680, with a decision classification of substantially equivalent (SESE). This means it meets FDA safety and performance standards comparable to legally marketed predecessors, ensuring compliance with cardiovascular device requirements.

  • Are there any specific storage instructions or considerations for this pacemaker lead before implantation?

    While the data does not specify storage conditions, as a sterile single-use device, it should be stored in its original packaging until use. Proper handling and adherence to manufacturer guidelines (if provided) are critical to maintaining sterility and functionality before implantation.