Quantum Bipolar Cardiac Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831633 ↗

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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• GE Lead Adapter, Model 345-01

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  FDA 510(k) K801040 Active Cleared 30 Jun 1980

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• Is the Quantum Bipolar Cardiac Pulse Generator designed for reuse or is it intended as a single-use implantable device?

  The Quantum Bipolar Cardiac Pulse Generator is explicitly designed for single-use within the body after surgical implantation. It is supplied sterile and intended to remain implanted permanently, so reuse is not applicable or recommended.

• How is the Quantum Bipolar Cardiac Pulse Generator packaged for surgical use, and is it sterile?

  The device is supplied sterile and packaged specifically for sterile field use during surgical implantation. This ensures proper aseptic conditions for the procedure, as required for an implantable cardiac device.

• Can this device be used in patients who require MRI scans, or is it MRI-safe?

  The Quantum Bipolar Cardiac Pulse Generator is not MRI-safe and is designed for use in environments where MRI procedures are not performed. Patients with this device should avoid MRI exposure due to potential risks.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The Quantum Bipolar Cardiac Pulse Generator was cleared through the FDA 510(k) pathway under the classification of a Class III medical device, which is the highest regulatory classification for devices requiring stringent premarket approval due to their critical role in patient safety. The clearance number is K831633, and it adheres to regulatory standards under 21 CFR 870.3610.

• What types of cardiac conditions is this device intended to address, and how does it regulate heart rhythm?

  This device is intended for patients with bradycardia or conduction disorders, generating electrical impulses to maintain consistent heart pacing. It uses a bipolar electrode configuration to deliver precise stimulation, ensuring reliable cardiac rhythm regulation for patients requiring artificial pacing.