Siemens-Elma Pulse Generator #718

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

510(k) Number

K830344 ↗

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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See all devices from Burditt & Calkins-Siemens-Elema →

• Is the Siemens-Elma Pulse Generator #718 designed for single-use or can it be reused in multiple procedures?

  The Siemens-Elma Pulse Generator #718 is supplied as a reusable component within a sterile packaging system. It is intended for use in cardiac electrophysiology procedures as part of an implantable pacemaker system, meaning it is not disposable but rather cleaned and reused after each procedure, adhering to sterile handling protocols.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Siemens-Elma Pulse Generator #718 received FDA clearance through a traditional 510(k) pathway, specifically under clearance number K830344. The device was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates implantable cardiac devices like pacemaker pulse generators.

• How is this device classified, and what does that mean for its use in clinical settings?

  The Siemens-Elma Pulse Generator #718 is classified as a Class III medical device, which means it carries higher risk and requires stringent regulatory oversight. This classification aligns with its role as an implantable pacemaker pulse generator, ensuring it meets rigorous safety and performance standards for use in regulating heart rhythm in patients with bradycardia or conduction disorders.

• What product code and regulation number does this device fall under, and what does that indicate about its intended use?

  The device is assigned the product code DXY and regulated under 21 CFR 870.3610, which pertains to implantable cardiac pacemakers. This classification confirms its role as a component of an implantable pacemaker system, designed to deliver electrical impulses for cardiac rhythm regulation, rather than any other therapeutic or diagnostic purpose.

• How is the device packaged for clinical use, and what does that imply about its handling?

  The Siemens-Elma Pulse Generator #718 is supplied in a sterile packaging system, which implies it must be handled under sterile conditions during implantation. While the device itself is reusable, the sterile packaging ensures contamination control during the procedure, requiring proper sterilization protocols between uses to maintain safety and efficacy.