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Porous Tip Endocardial Lead

by Daig Corp. 510(k)

Active United States

510(k) K830743

Overview

The Porous Tip Endocardial Lead is a permanent pacemaker electrode designed for endocardial pacing. It features a porous tip to facilitate tissue integration and stable electrode fixation within the heart’s endocardial lining, ensuring reliable electrical conduction for cardiac rhythm management.

This device is supplied sterile and intended for single-use implantation in cardiac electrophysiology procedures. It is classified as a Class III medical device under FDA regulations and requires a 510(k) clearance. The lead is compatible with MRI environments under specific conditions as outlined in its labeling, and multiple model variants are available to accommodate different patient anatomies and procedural requirements.

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 NumberK830743 Date9 May 1983ClearedStatusActive

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 types of patients is the Porous Tip Endocardial Lead designed to accommodate, and how does it ensure stable placement within the heart?

    The Porous Tip Endocardial Lead is designed for patients requiring permanent endocardial pacing, offering multiple model variants to suit different anatomies. Its porous tip facilitates tissue integration, which helps anchor the lead securely within the heart’s endocardial lining, ensuring stable electrical conduction for reliable cardiac rhythm management.

  • Is this lead reusable, or is it intended for single-use only? How is it supplied?

    The Porous Tip Endocardial Lead is intended for single-use only and is supplied sterile, ensuring safety and sterility for direct implantation during cardiac electrophysiology procedures. This design eliminates the need for reprocessing and reduces infection risks.

  • Can this lead be used in patients who require MRI scans, and if so, what conditions apply?

    Yes, the Porous Tip Endocardial Lead is compatible with MRI environments under specific conditions, as outlined in its labeling. However, the exact parameters (e.g., MRI strength, safety protocols) must be reviewed in the device’s instructions to ensure safe use.

  • How many model variants of this lead are available, and what determines the selection of a specific variant?

    Multiple model variants of the Porous Tip Endocardial Lead are available, as indicated by the listed FEI numbers. The selection depends on patient anatomy, procedural requirements, and lead specifications (e.g., length, tip design) to ensure proper fit and function during endocardial pacing.