Model 230-05 Cyberlith I Bipol. Pulse G.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810800 ↗

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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• What is the primary purpose of the Model 230-05 Cyberlith I Bipolar Pulse Generator, and who should use it?

  The Model 230-05 Cyberlith I Bipolar Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart, specifically for patients requiring cardiac pacing support. It is intended for single-use implantation by qualified medical professionals in clinical settings, such as cardiologists or electrophysiologists, for patients with conditions necessitating pacemaker therapy.

• Is this device reusable or intended for single-use, and how is it supplied?

  This device is explicitly intended for single-use only. It is supplied sterile, ensuring readiness for immediate implantation by qualified medical professionals without the need for additional sterilization procedures.

• What regulatory pathway was followed for the clearance of this device, and what classification does it hold?

  The Model 230-05 Cyberlith I Bipolar Pulse Generator was cleared through the FDA’s traditional review pathway under a 510(k) submission, with a decision of ‘Substantially Equivalent.’ It is classified as a Class III medical device, reflecting its critical role in regulating cardiac rhythm and the associated regulatory scrutiny.

• How should this device be stored, and what considerations should be made before use?

  While specific storage instructions are not detailed in the provided data, the device is supplied sterile and intended for single-use implantation. Clinicians should follow standard sterile handling protocols for implantable medical devices, ensuring the packaging remains unopened and uncontaminated until immediate use in a controlled clinical environment.

• What types of patients or clinical scenarios would typically require this type of device?

  This device is intended for patients with cardiac conditions that necessitate artificial pacing, such as bradycardia (slow heart rate), heart block, or other arrhythmias where the heart’s natural electrical system is impaired. It is used in clinical settings where qualified professionals can implant and program the device to deliver precise electrical impulses to maintain a stable heart rhythm.