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Daig Type O4 VS-1 Connector

by Daig Corp. 510(k)

Active United States

510(k) K863921

Overview

The Daig Type O4 VS-1 Connector is a Permanent Pacemaker Electrode, designed as a specialized connector for use with cardiac pacing systems. It facilitates electrical connectivity between the pacemaker generator and the electrode lead, ensuring reliable signal transmission for cardiac rhythm management.

This connector is supplied as a reusable component, intended for integration within permanent pacemaker systems. It is classified under FDA regulation number 870.3680 and was granted FDA 510K clearance under the traditional review pathway, with a decision of Substantially Equivalent by the Cardiovascular Advisory Committee. No specific sterility or MRI safety information is 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 NumberK863921 Date24 Nov 1986ClearedStatusActive

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 Daig Type O4 VS-1 Connector used for in cardiac pacing systems?

    The Daig Type O4 VS-1 Connector is a specialized reusable component designed to establish a permanent electrical connection between a pacemaker generator and the electrode lead. Its purpose is to ensure reliable signal transmission for managing cardiac rhythm, making it essential for long-term pacing applications.

  • Is the Daig Type O4 VS-1 Connector intended for single-use or can it be reused?

    The Daig Type O4 VS-1 Connector is explicitly described as a reusable component, intended for integration within permanent pacemaker systems. It is not labeled for single-use, allowing for repeated use in compatible cardiac pacing setups.

  • What regulatory pathway was followed for FDA clearance of this connector?

    The Daig Type O4 VS-1 Connector received FDA 510(k) clearance through the traditional review pathway. Its classification as substantially equivalent was determined by the Cardiovascular Advisory Committee, ensuring compliance with FDA regulation number 870.3680 for permanent pacemaker electrodes.

  • Are there any specific storage instructions or sterility considerations mentioned for this connector?

    The provided data does not include explicit sterility requirements or storage instructions for the Daig Type O4 VS-1 Connector. Since it is reusable, proper cleaning and handling protocols would typically be required, but these details are not specified in the documentation.