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Cardiac Pacemaker S6001

by Vitatron Medical BV 510(k)

Active United States

510(k) K772009

Overview

The Cardiac Pacemaker S6001 is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing.

This device is supplied sterile and intended for single-use implantation by a qualified healthcare professional. It is regulated under FDA 510(k) clearance (K772009) and falls under the Implantable Pacemaker Pulse-Generator category (DXY, regulation 870.3610). No MRI safety information or reusable specifications are provided in the data.

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 NumberK772009 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 clinical purpose of the Cardiac Pacemaker S6001 and who should consider using it?

    The Cardiac Pacemaker S6001 is designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle, specifically for patients diagnosed with bradycardia or other conduction disorders requiring chronic cardiac pacing. It is intended for implantation by qualified healthcare professionals in patients who need long-term pacing support due to slow heart rates or electrical signal conduction issues.

  • Is the Cardiac Pacemaker S6001 intended for reuse or is it meant to be used only once?

    The Cardiac Pacemaker S6001 is explicitly intended for single-use implantation. It is supplied sterile and should not be reused after implantation, as this could compromise patient safety and device efficacy.

  • What regulatory pathway was followed for the approval of this device, and which committee was involved?

    The Cardiac Pacemaker S6001 was cleared through the FDA’s 510(k) pathway, specifically under a Traditional review process. The device was evaluated by the Cardiovascular (CV) Advisory Committee, which is responsible for reviewing cardiovascular-related medical devices.

  • What types of patients or clinical scenarios would this device be relevant for?

    This device is relevant for patients with chronic bradycardia or conduction disorders that require consistent cardiac pacing. It is not intended for acute or temporary pacing needs but rather for long-term management of heart rhythm abnormalities in patients who have been diagnosed with conditions necessitating permanent pacing support.