Programmable Bipolar Cardiac Generator

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

510(k) Number

K800837 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Arcolith 2000 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K791715 Active Cleared 27 Sep 1979

• Unipolar Programmable Lithium Card. Gen.

  Class III

  FDA 510(k) K801241 Active Cleared 30 Jun 1980

• ArcoBiolith Pacemaker Model

  Class III

  FDA 510(k) K780776 Active Cleared 3 Oct 1978

• Decubitus Mattress

  Class I

  FDA 510(k) K760963 Active Cleared 18 Nov 1976

• Arcolith 3022&Arcolith 3023 Cardiac Gen.

  Class III

  FDA 510(k) K800838 Active Cleared 4 Jun 1980

• Pacemaker & Cardiac Lead, Bipolar

  Class III

  FDA 510(k) K771262 Active Cleared 21 Jul 1977

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• What clinical conditions is this device designed to address in patients?

  This Programmable Bipolar Cardiac Generator is specifically designed to manage bradycardia (slow heart rate) and conduction disorders by delivering precise electrical pacing impulses to the heart. Its programmable bipolar configuration allows clinicians to adjust pacing parameters like output amplitude and pulse width to match individual patient needs, ensuring reliable cardiac rhythm regulation.

• How is this device supplied, and what precautions must be taken before use?

  The device is supplied as a single-use, sterile component and must be handled within a sterile operating environment prior to implantation. It comes in sterile packaging, and proper handling is critical to maintain sterility and functionality. Always follow the manufacturer’s guidelines for storage and preparation to ensure compliance with surgical standards.

• Is this device reusable, or is it intended for one-time use only?

  This device is intended for single-use only after implantation. It is not designed for reuse, and its sterile packaging ensures it remains suitable for one surgical procedure. Reuse could compromise sterility and device performance, posing risks to patient safety.

• What regulatory pathway does this device follow, and how does that affect its use?

  This device follows the FDA 510(k) clearance pathway (K800837) under classification DXY and regulation 870.3610, confirming it meets safety and performance standards for implantable pacemaker pulse-generators. The clearance indicates it is substantially equivalent to a predicate device, ensuring compliance with cardiovascular device regulations. Clinicians should verify the specific clearance details when procuring or using it.

• What storage requirements must be followed to ensure the device remains functional before surgery?

  The device must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Since it is single-use and sterile-packaged, it should be kept in its original packaging until immediately before implantation. Exposure to moisture, extreme temperatures, or contamination could compromise its performance, so adherence to storage guidelines is essential.