Pulse Generator 718B & 718L

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

510(k) Number

K841228 ↗

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

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  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

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• What is the primary purpose of the Pulse Generator 718B & 718L in clinical practice?

  The Pulse Generator 718B & 718L is designed to regulate heart rhythm by delivering electrical impulses to patients with bradycardia or other cardiac conduction disorders. It acts as the power source and control unit for pacing systems, ensuring consistent and programmable cardiac stimulation.

• Is this device intended for single-use or can it be reused in multiple patients?

  The Pulse Generator 718B & 718L is explicitly described as a reusable Class III medical device. While it is regulated under sterile medical device protocols, it is not intended for single-use implantation in multiple patients. Proper storage and handling must comply with sterile medical device guidelines to ensure safety and functionality.

• How is this device regulated by the FDA, and what does that mean for its use?

  The Pulse Generator 718B & 718L holds FDA 510(k) clearance (K841228) under the product code DXY and regulation number 870.3610, confirming it is classified as a Class III device. This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for use in cardiovascular procedures, specifically as an implantable pacemaker pulse-generator.

• Are there different models or sizes available for the Pulse Generator 718B & 718L?

  The provided data does not specify distinct sizes or models beyond the two listed variants (718B and 718L). However, the OpenFDA registration numbers suggest multiple FEI (Facility Device) registrations under this device name, which may indicate variations in batch or manufacturing lot distinctions. Clinicians should confirm with Siemens Elema AB or the distributor for specific model differences or compatibility with pacing systems.

• What storage and handling precautions should be taken for this device?

  Though the data does not detail sterility assurance (e.g., terminal sterilization methods), the Pulse Generator 718B & 718L is regulated as a sterile medical device for implantation. It must be stored and handled according to sterile medical device protocols to prevent contamination. Since it is reusable, proper cleaning, sterilization, and maintenance procedures (e.g., autoclave or chemical sterilization) are critical before reuse in patients.