Cyberlith IX Quantum-Unipolar Cardiac

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K823863 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What types of cardiac conditions is the Cyberlith IX Quantum-Unipolar Cardiac designed to treat, and how does it work?

  The Cyberlith IX Quantum-Unipolar Cardiac is designed to treat patients with bradycardia or conduction disorders by regulating cardiac rhythm. It achieves this through unipolar pacing, delivering controlled electrical impulses to the heart to maintain a proper heartbeat. This device is specifically intended for implantable use and is not meant for external or temporary pacing applications.

• Is the Cyberlith IX Quantum-Unipolar Cardiac meant for single-use or can it be reused after implantation?

  The Cyberlith IX Quantum-Unipolar Cardiac is supplied as a single-use implantable component. It is intended for one-time surgical implantation by qualified healthcare professionals and is not designed for reuse. Sterile handling is required during the implantation process to ensure patient safety.

• What regulatory pathway was followed for the clearance of this device, and what does that mean for its use?

  The Cyberlith IX Quantum-Unipolar Cardiac was cleared through the Traditional 510(k) pathway by the FDA in 1983, with a decision code indicating it was determined to be substantially equivalent to a legally marketed device. This means it meets FDA standards for safety and effectiveness as an Implantable Pacemaker Pulse-Generator, but it does not imply ongoing approval for all future use—only that it complies with the regulatory requirements at the time of clearance.

• How should the Cyberlith IX Quantum-Unipolar Cardiac be stored before implantation, and what precautions should be taken?

  Since the Cyberlith IX Quantum-Unipolar Cardiac is a sterile, single-use implantable device, it must be stored according to manufacturer guidelines to maintain sterility. Proper storage typically involves keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight. Only qualified healthcare professionals should handle it, and it should be implanted in a controlled surgical environment to ensure patient safety.