Siemens-Elema Pulse Generator 678

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K802864 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K861625 Active Cleared 2 May 1986

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  Class II

  FDA 510(k) K861707 Active Cleared 19 Jun 1986

• Siemens-Elema Pulse Generator 625

  Class III

  FDA 510(k) K801508 Active Cleared 16 Sep 1980

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  FDA 510(k) K802816 Active Cleared 16 Jan 1981

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  Class I

  FDA 510(k) K840326 Active Cleared 7 Jun 1984

• Pacemaker Sys. Analyzer 378

  Class II

  FDA 510(k) K832959 Active Cleared 14 Nov 1983

See all devices from Siemens Elema AB →

• What is the primary clinical purpose of the Siemens-Elema Pulse Generator 678 and how does it function in patients?

  The Siemens-Elema Pulse Generator 678 is designed to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders by delivering consistent electrical pacing impulses. As an implantable pacemaker pulse-generator, it ensures proper cardiac function by stimulating the heart when its natural electrical signals are insufficient.

• Is the Siemens-Elema Pulse Generator 678 intended for single-use or reusable applications, and what handling precautions should be taken?

  The device is supplied as a reusable component within a cardiovascular setting, meaning it is not single-use. Since it requires surgical implantation, sterile handling and proper storage are critical to maintain functionality and prevent contamination.

• What regulatory pathway was followed for the approval of this device, and what does that mean for its use in clinical settings?

  The Siemens-Elema Pulse Generator 678 received FDA clearance through a 510(k) submission, specifically classified as substantially equivalent to prior generations. This means it was evaluated against existing pacemaker pulse-generators and determined to meet regulatory standards (21 CFR 870.3610) for safety and effectiveness, ensuring its use aligns with established clinical practices.

• How is the device categorized in terms of medical specialty and regulatory classification?

  The Siemens-Elema Pulse Generator 678 falls under the cardiovascular medical specialty and is classified as a Class III device (device_class=3) per FDA regulations. This classification reflects its role as an implantable pacemaker pulse-generator, requiring rigorous oversight due to its direct impact on patient health.