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Endocardial Bipolar Lead

by American Technology, Inc.

510(k) K781456

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 NumberK781456 Date4 Dec 1978ClearedStatusActive

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  • Withdrawn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)

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 Endocardial Bipolar Lead is a Permanent Pacemaker Electrode designed for endocardial implantation, providing bipolar electrical pacing and sensing within the heart chambers. It facilitates cardiac rhythm management by delivering precise electrical stimuli to the myocardium, ensuring synchronized contractions for patients with bradycardia or conduction disorders.

This device is intended for surgical implantation by cardiologists or electrophysiologists in a sterile operating room setting. Supplied as a single-use, non-sterile product (sterilized prior to use), it adheres to FDA 510(k) clearance (K781456) under classification DTB, with regulatory compliance to 870.3680. Available in multiple model variants, it requires proper handling, storage in a clean, dry environment, and adherence to manufacturer instructions for sterilization before clinical use.

Other devices from American Technology, Inc.

Questions

AI-generated answers, 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.

  • What types of patients is this Endocardial Bipolar Lead designed to support, and how is it implanted?

    This lead is designed for patients with bradycardia or conduction disorders requiring cardiac rhythm management. It is surgically implanted by cardiologists or electrophysiologists in a sterile operating room setting, positioned endocardially to deliver precise electrical pacing and sensing within the heart chambers.

  • Is the Endocardial Bipolar Lead intended for single-use or can it be reused after sterilization?

    The lead is supplied as a single-use device but is sterilized by the manufacturer prior to use. It is not intended for reuse after clinical implantation, and proper sterilization procedures must be followed before initial use as instructed by the manufacturer.

  • How should this device be stored before use, and what storage conditions are recommended?

    The Endocardial Bipolar Lead should be stored in a clean, dry environment before use. Since it is supplied non-sterile but sterilized prior to clinical application, storage conditions must prevent contamination until sterilization is completed as per manufacturer guidelines.

  • What regulatory pathway does this device follow, and which committee reviewed its submission?

    This device follows the FDA 510(k) clearance pathway, specifically under classification DTB (Dental, Ophthalmic, and Surgical) with a traditional review process. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Permanent Pacemaker Electrode.