Skip to content

Cardial Pulse Generators

by Telectronics, Inc.

510(k) K781426

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 NumberK781426 Date7 Sep 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  • Withdrawn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
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.

The Cardial Pulse Generators are implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are classified as Class III medical devices, indicating their high-risk nature and critical role in sustaining life for patients with bradycardia or other cardiac conduction disorders.

These devices are intended for surgical implantation and are regulated under FDA 510(k) clearance (K781426), with a product code of DXY. They are supplied sterile and intended for single-use implantation, adhering to strict regulatory standards for implantable cardiac devices. The devices are manufactured by Telectronics, Inc., and their use is governed by the FDA’s Premarket Notification process for Class III devices.

Other devices from Telectronics, Inc.

See all devices from Telectronics, Inc. →