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Endo-Lok L-40 Endocardial Pacing Electrode

by Coratomic, Inc.

510(k) K760714

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760714 Date14 Dec 1976ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Endo-Lok L-40 Endocardial Pacing Elect.
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

Overview

AI-generated summary, 18 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 Endo-Lok L-40 Endocardial Pacing Electrode is a permanent pacemaker electrode designed for endocardial pacing. It is classified as a Permanent Pacemaker Electrode and is intended for use in cardiovascular applications, providing electrical stimulation to the heart tissue to regulate cardiac rhythm.

This device is supplied sterile and is intended for single-use implantation within the heart. It is regulated under the FDA 510(k) clearance with a decision classification of Substantially Equivalent, falling under the Device Type DTB and Regulation Number 870.3680. The electrode is manufactured by Coratomic, Inc., and is intended for use in controlled clinical settings, adhering to strict sterility and handling protocols.

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