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Pulse Generator 698, 698B & 698L

by Siemens Elema AB

510(k) K841229

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 NumberK841229 Date25 Jun 1984ClearedStatusActive

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  • Withdrawn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 Pulse Generator 698, 698B & 698L is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This Class III device is intended for patients requiring consistent pacing support, ensuring proper heart function in conditions such as bradycardia or heart block.

These pulse generators are supplied as reusable medical devices and are regulated under FDA 510(k) clearance (K841229) with a traditional review process. They are classified under product code DXY and fall under the Cardiovascular specialty, adhering to regulatory standards for high-risk, life-sustaining devices. No additional sterility or MRI safety specifications are noted in the available data.

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