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Cardiac Pacemaker C2001

by Vitatron Medical BV 510(k)

Active United States

510(k) K772010

Overview

The Cardiac Pacemaker C2001 is an Implantable Pacemaker Pulse-Generator, classified under product code DXY. It is designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle, ensuring proper cardiac pacing in patients with bradycardia or other conduction disorders.

This device is intended for implantable use within the cardiovascular system and has received FDA 510(k) clearance under the Traditional review pathway. Supplied as a sterile, single-use implantable component, it adheres to Class III regulatory standards for high-risk, life-sustaining medical devices. Authorized under regulation number 870.3610, it was cleared in 1977 for distribution in the United States.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK772010 Date28 Nov 1977ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
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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Questions

  • What is the primary purpose of the Cardiac Pacemaker C2001 and how does it function in the body?

    The Cardiac Pacemaker C2001 is designed to regulate abnormal heart rhythms by delivering controlled electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia or conduction disorders, ensuring proper cardiac pacing to maintain a stable heart rate.

  • Is the Cardiac Pacemaker C2001 intended for reuse or is it meant to be implanted as a single-use device?

    The Cardiac Pacemaker C2001 is supplied as a sterile, single-use implantable component. Once implanted, it is intended to remain in place as a permanent solution for the patient’s cardiac pacing needs.

  • What regulatory pathway was followed for the FDA clearance of this device, and when was it originally cleared?

    The Cardiac Pacemaker C2001 received FDA 510(k) clearance under the Traditional review pathway in 1977. It was authorized under regulation number 870.3610 and classified as a Class III device, reflecting its high-risk, life-sustaining nature.

  • How is the device categorized in terms of medical specialty, and what does this imply for its use?

    The device falls under the medical specialty of Cardiovascular, indicating it is specifically engineered for use within the cardiovascular system to address pacing-related disorders. This classification aligns with its role in treating bradycardia or conduction abnormalities.

  • Are there multiple models or variations of the Cardiac Pacemaker C2001, or is it a singular device?

    The provided data lists multiple registration numbers (e.g., 2017865, 3005334138) under the Cardiac Pacemaker C2001, which may imply variations or different lots/serial numbers rather than distinct models. However, the core design and function remain consistent as an Implantable Pacemaker Pulse-Generator.