MIKROS VS-1 Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Mikros, Mikros Vs-1, Pulse Generator

510(k) Number

K860922 ↗

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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• Leptos Implantable Pacemaker Pulse-Generator

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• EDP-20 Pacemaker

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• Pulse Generator

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  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

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  FDA 510(k) K863480 Active Cleared 23 Sep 1986

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• What is the primary purpose of the MIKROS VS-1 Pulse Generator, and who should use it?

  The MIKROS VS-1 Pulse Generator is designed to deliver electrical impulses for regulating cardiac rhythm in patients with bradycardia or conduction disorders. It is intended for use in patients requiring cardiac pacing to maintain proper heart function, specifically those who need an implantable solution to support their heart’s electrical activity.

• Is the MIKROS VS-1 Pulse Generator reusable or single-use, and how should it be handled?

  The MIKROS VS-1 Pulse Generator is a sterile, single-use device. It must be handled according to sterile medical device protocols to preserve its integrity and ensure patient safety during surgical implantation by qualified healthcare professionals.

• What regulatory pathway does the MIKROS VS-1 Pulse Generator follow, and what does that mean for its use?

  The MIKROS VS-1 Pulse Generator follows the FDA 510(k) clearance pathway, specifically under clearance number K860922, and is classified as a Class III device. This means it has undergone a review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness for its intended use in cardiac pacing.

• How should the MIKROS VS-1 Pulse Generator be stored before use?

  Since it is a sterile, single-use implantable device, the MIKROS VS-1 Pulse Generator must be stored in accordance with standard sterile medical device protocols. This includes maintaining proper packaging integrity, protecting it from contamination, and adhering to manufacturer guidelines to ensure it remains safe for surgical implantation.