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Lead, Sutureless Myocardial

by Daig Corp. 510(k)

Active United States

510(k) K800355

Overview

This device is a Permanent Pacemaker Electrode, designed for myocardial pacing without the need for sutures. It is intended for use in patients requiring cardiac pacing, particularly in scenarios where traditional suture-based leads are impractical or challenging to implant.

The Lead, Sutureless Myocardial is supplied as a sterile, single-use implantable device and falls under the DTB product code classification. It is regulated under FDA 510(k) clearance (K800355) and classified as a Class 3 Cardiovascular device under 21 CFR 870.3680. Storage and handling must comply with sterile medical device protocols.

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 NumberK800355 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

  • What is the primary advantage of using the Daig Corp. Lead, Sutureless Myocardial over traditional suture-based pacemaker leads?

    The Daig Corp. Lead, Sutureless Myocardial is designed specifically to eliminate the need for sutures during implantation, making it ideal for patients where traditional leads are difficult to secure. This feature simplifies the procedure and reduces potential complications related to suturing, such as tissue trauma or displacement.

  • Is this device intended for temporary or permanent cardiac pacing, and how is it supplied?

    This device is intended for permanent cardiac pacing, as explicitly stated in its description. It is supplied as a sterile, single-use implantable lead, ensuring it meets strict medical device sterility standards and is not meant for reuse.

  • How should the Lead, Sutureless Myocardial be stored, and what precautions should be taken?

    Since it is a sterile, single-use device, storage must comply with standard sterile medical device protocols to maintain integrity. This includes keeping it in its original packaging, protected from moisture, contamination, and extreme temperatures until immediate use.

  • What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

    The Lead, Sutureless Myocardial received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). It is classified as a Class 3 Cardiovascular device under 21 CFR 870.3680, indicating it is subject to stringent regulatory oversight due to its role in life-sustaining or supporting functions.