Siemens-Elema Pulse Generator 668

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

510(k) Number

K801324 ↗

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 668 in a clinical setting?

  The Siemens-Elema Pulse Generator 668 is designed to regulate heart rhythm by delivering electrical impulses to patients with bradycardia or cardiac conduction disorders. It serves as an implantable component in a pacemaker system to ensure consistent and reliable cardiac stimulation.

• Is this device intended for single-use or can it be reused after implantation?

  The Siemens-Elema Pulse Generator 668 is explicitly described as a reusable component within a pacemaker system. It requires proper storage and maintenance to ensure functionality and patient safety, as outlined by the manufacturer.

• What type of regulatory clearance does this device hold, and how was it determined?

  The Siemens-Elema Pulse Generator 668 holds FDA 510(k) clearance (K801324) with a decision labeled as *Substantially Equivalent*. This classification was determined through a traditional review process by the FDA’s Cardiovascular (CV) advisory committee, confirming its compliance with existing pacemaker standards.

• How should this device be handled during and after implantation to maintain sterility?

  Since the device is implanted, sterile handling protocols must be strictly followed during the procedure. While the device itself is reusable, its components and related materials must adhere to manufacturer guidelines for storage and maintenance to prevent contamination and ensure long-term reliability.

• What medical specialty is primarily responsible for using this device, and where was it originally reviewed?

  This device falls under the *Cardiovascular* medical specialty and was originally reviewed by the FDA’s Cardiovascular (CV) advisory committee. It is intended for use by trained medical professionals in clinical settings specializing in cardiac pacing.