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Implantable Cardiac Pulse Generator

by Telectronics, Inc.

510(k) K782149

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 NumberK782149 Date8 Feb 1979ClearedStatusActive

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  • Withdrawn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
Pulse Generator, Implantable Cardiac
510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
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.

This device is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients with bradycardia or other conduction disorders requiring artificial pacing to maintain normal heart function.

The pulse generator is implanted subcutaneously and is typically supplied sterile for single-use implantation. It is regulated under FDA 510(k) clearance (K782149) and falls under the Implantable Pacemaker Pulse-Generator nomenclature (DXY, regulation 870.3610). Compatible with MRI environments under specific conditions, it is available in various models as referenced in the registration numbers.

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