Thinlith III Unipolar Cardiac Pulse Gen.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810752 ↗

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 Thinlith III Unipolar Cardiac Pulse Generator and how does it function in the body?

  The Thinlith III Unipolar Cardiac Pulse Generator is designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. As a unipolar device, it uses a single electrode for pacing, ensuring consistent stimulation to maintain proper heart function in patients requiring chronic cardiac support.

• Is this device intended for single-use or can it be reused after implantation?

  The Thinlith III Unipolar Cardiac Pulse Generator is supplied sterile and intended for single-use implantation. However, clinical practice may involve reusing certain reusable components of the system, depending on facility protocols and regulatory guidelines.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?

  The Thinlith III Unipolar Cardiac Pulse Generator was cleared through the FDA’s 510(k) pathway under clearance number K810752, with a decision of ‘Substantially Equivalent.’ It was reviewed by the Cardiovascular (CV) Advisory Committee in 1981, as part of its traditional clearance process.

• Does this device comply with MRI safety standards for implantable cardiac devices?

  Yes, the Thinlith III Unipolar Cardiac Pulse Generator is explicitly noted to remain compliant with MRI safety standards for implantable cardiac devices, ensuring compatibility with magnetic resonance imaging procedures when clinically indicated.

• What classification does this device hold under FDA regulations, and why is this relevant?

  The Thinlith III Unipolar Cardiac Pulse Generator is classified as a Class III medical device under FDA regulation (870.3610), which means it requires strict premarket approval due to its role in regulating life-sustaining or life-supporting functions, such as chronic cardiac pacing.