Cyberlith Bipolar Cardiac Implantable Pacemaker Pulse-Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Intermedics Cyberlith Bipolar Cardiac

510(k) Number

K811221 ↗

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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  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

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  FDA 510(k) K844270 Active Cleared 28 Mar 1985

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  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Cyberlith Bipolar Cardiac device, and how does it function in the body?

  The Cyberlith Bipolar Cardiac Implantable Pacemaker Pulse-Generator is designed to regulate heart rhythm by delivering controlled electrical impulses. It is intended for patients with bradycardia or other cardiac conduction disorders, ensuring the heart beats at a consistent and appropriate rate to maintain proper cardiac function.

• Is this device intended for reuse, or is it meant to be used only once after opening?

  The Cyberlith Bipolar Cardiac device is supplied sterile and explicitly intended for single-use only. This means it must not be reused after implantation, as reuse could compromise sterility and patient safety.

• How should the device be stored to maintain its integrity before use?

  The device must be stored and handled according to sterile medical device protocols to preserve its sterility. Since it is supplied sterile for single-use, proper storage conditions—such as in a sealed, sterile packaging—are critical to prevent contamination before implantation.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and efficacy?

  The Cyberlith Bipolar Cardiac device received FDA 510(k) clearance (K811221) under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets established safety and effectiveness standards for an Implantable Pacemaker Pulse-Generator.

• Can this device be safely used in patients who require MRI scans, and if so, what limitations apply?

  The Cyberlith Bipolar Cardiac device is designed to operate within MRI-safe parameters, as defined by its regulatory classification. However, specific MRI safety guidelines must be followed, including restrictions on MRI strength and sequence types, to ensure patient safety during imaging procedures. Always consult the device’s labeling or manufacturer instructions for precise MRI compatibility details.