Siemens-Elema Pulse Generator 659

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

510(k) Number

K813576 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Servo Gas Monitor 120

  Class II

  FDA 510(k) K861625 Active Cleared 2 May 1986

• Master Program Flow & Pressure CO2 & Lung Monitor

  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

• Endocardial Leads 414S & 515S

  Class III

  FDA 510(k) K802816 Active Cleared 16 Jan 1981

• Gas Supply Manifold Siemens-Elema Ab

  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 purpose of the Siemens-Elema Pulse Generator 659 in clinical settings?

  The Siemens-Elema Pulse Generator 659 is designed to regulate heart rhythm by delivering electrical impulses to patients with bradycardia or other cardiac conduction disorders. It serves as an implantable pacemaker component to ensure consistent and reliable cardiac stimulation, helping maintain proper heart function in patients requiring chronic pacing support.

• Is the Siemens-Elema Pulse Generator 659 intended for single-use or reusable applications?

  The device is explicitly described as a reusable component within a pacemaker system. It is not intended for single-use and must be handled in sterile conditions during implantation by qualified medical professionals, as it is implanted directly into the patient.

• How is the regulatory status of this device determined, and what does that mean for its use?

  The Siemens-Elema Pulse Generator 659 was granted FDA 510(k) clearance (K813576) with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it meets the same performance standards as an existing approved pacemaker pulse generator, ensuring its safety and effectiveness for use in cardiac pacing applications under the specified regulatory framework (870.3610).

• What type of clinical environment or setting is required for implantation of this device?

  The device must be implanted by qualified medical professionals in a clinical setting, as it is intended for sterile conditions. This ensures proper surgical techniques and adherence to infection control protocols during the procedure, which is critical for an implantable medical device like this pulse generator.

• Are there specific models or variations of the Siemens-Elema Pulse Generator 659, or is it a singular device?

  The provided data describes the device as a single model: the Siemens-Elema Pulse Generator 659, without mentioning specific variants or sizes. However, it is classified under OpenFDA’s registration numbers and product code (DXY) for *Implantable Pacemaker Pulse-Generators*, which may include related configurations or updates over time—always verify with the manufacturer for current offerings.