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Siemens-Elema Pulse Generator 668 B

by Siemens Corp.

510(k) K812610

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 NumberK812610 Date10 Dec 1981ClearedStatusActive

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  • Withdrawn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 Siemens-Elema Pulse Generator 668 B is an implantable pacemaker pulse-generator, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. It serves as the power source and control unit for pacing systems, ensuring consistent and programmable cardiac stimulation.

This device is intended for surgical implantation and is classified as a Class III medical device under FDA regulations. Supplied sterile and intended for single-use, it requires proper handling and storage as outlined in the manufacturer’s instructions. Authorized under FDA 510(k) clearance (K812610), it adheres to regulatory standards for cardiovascular implants, including compliance with 21 CFR 870.3610.

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