Intermedics Cyberlith I Biopolar Cardi

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810383 ↗

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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  Class III

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

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• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What clinical conditions is the Cyberlith I Bipolar Cardi intended to address in patients requiring permanent pacing?

  The Cyberlith I Bipolar Cardi is designed for patients with bradycardia, heart block, or other conduction disorders where the heart’s natural electrical system fails to maintain an adequate rhythm. It delivers programmable electrical impulses to regulate cardiac rhythm and restore consistent heart function, ensuring reliable pacing for those dependent on permanent cardiac support.

• Is the Cyberlith I Bipolar Cardi reusable, or is it intended for single-use implantation?

  The Cyberlith I Bipolar Cardi is explicitly supplied sterile and intended for single-use implantation only. This aligns with standard sterile medical device protocols to prevent infection and ensure patient safety during surgical procedures.

• How should the Cyberlith I Bipolar Cardi be stored to maintain its sterility and functionality?

  Since it is supplied sterile, storage must follow strict sterile medical device protocols to preserve integrity. The device should be kept in its original packaging, protected from moisture, extreme temperatures, and physical damage until immediate use in a clinical setting.

• What regulatory pathway does the Cyberlith I Bipolar Cardi follow, and how does this affect its use?

  The Cyberlith I Bipolar Cardi was cleared via the FDA 510(k) pathway (K810383) under the classification for Implantable Pacemaker Pulse-Generators (DXY). This clearance confirms it meets FDA standards for safety and effectiveness as a Class III device, governed by 21 CFR 870.3610, ensuring compliance with implantable cardiac device regulations.