Implantable Programmable Unipolar Pacemaker Pulse-Generator

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

Full name

Implantable Programmable Unipolar

510(k) Number

K792519 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

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• What types of heart conditions is this unipolar pacemaker designed to treat, and how does its unipolar configuration benefit patients?

  This device is specifically designed to manage abnormal heart rhythms by delivering electrical impulses to stimulate the heart muscle, ensuring consistent pacing for patients with bradycardia or conduction disorders. The unipolar configuration simplifies implantation by using a single electrode pathway, which reduces complexity compared to bipolar systems and may lower the risk of complications during surgery.

• Is this pacemaker meant for reuse, or is it intended for single-patient use only? How should it be stored to maintain its integrity?

  This device is supplied sterile and intended for single-patient use only, as explicitly stated in the data. To maintain sterility and functionality, it must be stored according to the manufacturer’s instructions, which likely include keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight until use.

• What are the key model variants or registration numbers associated with this pacemaker, and how can I verify compatibility with my patient’s needs?

  This device comes in multiple model variants, each identified by specific registration numbers such as 2017865, 3005334138, 2024024, and others listed in the data. To ensure compatibility, verify the exact model number against your patient’s clinical requirements and consult the manufacturer’s documentation or technical specifications for detailed features, programming capabilities, and MRI compatibility (if applicable).

• How is this device regulated, and what does the FDA’s 510(k) clearance (K792519) imply about its safety and effectiveness?

  This pacemaker is regulated under the FDA’s 510(k) clearance process (K792519), which means it has been determined to be substantially equivalent to a legally marketed device in terms of technology and safety. The clearance was granted by the Cardiovascular (CV) Advisory Committee, indicating it meets FDA standards for managing bradycardia and conduction disorders. However, final clinical decisions should always align with your institution’s protocols and patient-specific needs.

• Can this pacemaker be used in patients who require MRI scans, and what limitations or conditions apply?

  While this device is compatible with MRI environments under specific conditions, those conditions are defined in its OpenFDA listing. Before any MRI procedure, strict adherence to the manufacturer’s guidelines—such as MRI-safe positioning, field strength limits, and imaging protocols—must be followed to avoid interference or device malfunction. Always confirm the latest MRI compatibility details with the manufacturer or device documentation.