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Adapter, Lead, General Electric

by Cardiac Pacemakers, Inc.

510(k) K770042

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770042 Date12 Jan 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTD
Device Class
Class II
Regulation
21 CFR Part 870.3620
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Adapter, Lead, General Electric is a pacemaker lead adaptor, classified as a class 2 device. It is used in cardiovascular applications, specifically with ECG and pacemaker systems. The device is designed to connect leads to a pacemaker or ECG machine, facilitating the transmission of cardiac signals. It is a crucial component in monitoring cardiac function and detecting potential abnormalities.

The Adapter, Lead, General Electric is supplied as a single unit, with various sizes and configurations available. It is a reusable device, designed for use in medical settings such as hospitals and private practices. The device has been cleared by the FDA under the traditional clearance type, with a decision code of SESE, indicating substantial equivalence. The device is regulated under the regulation number 870.3620, and has been assigned a product code of DTD.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Adapter, Lead, General Electric used for?

    The Adapter, Lead, General Electric is used to connect leads to a pacemaker or ECG machine, facilitating the transmission of cardiac signals and monitoring cardiac function.

  • Is the Adapter, Lead, General Electric reusable?

    Yes, the Adapter, Lead, General Electric is a reusable device, designed for use in medical settings such as hospitals and private practices.

  • What sizes and configurations are available for the Adapter, Lead, General Electric?

    The Adapter, Lead, General Electric is supplied as a single unit, with various sizes and configurations available to accommodate different medical needs.

  • How is the Adapter, Lead, General Electric regulated?

    The device is regulated under the regulation number 870.3620 and has been assigned a product code of DTD, indicating its classification as a class 2 device.