Pacemakers, Vitatrons (Series 3000)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760671 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacemakers, Vitatron's

  Class III

  FDA 510(k) K760669 Active Cleared 12 Nov 1976

• Cardiac Pacemaker P4000 Ser. & P1000

  Class III

  FDA 510(k) K791920 Active Cleared 29 Nov 1979

• Cardiac Pacemaker C4000, C1000 Ser.

  Class III

  FDA 510(k) K791921 Active Cleared 26 Oct 1979

• External Test Pulse Generator

  Class II

  FDA 510(k) K780717 Active Cleared 30 Jun 1978

• Electrode Pacemaker, Perm & Temp

  Class III

  FDA 510(k) K840668 Active Cleared 24 Sep 1984

• Endocardial Electrode

  Class III

  FDA 510(k) K810928 Active Cleared 2 Jul 1981

See all devices from Vitatron Medical BV →

• What is the primary purpose of the Vitatron Series 3000 Pacemakers, and who would benefit from using them?

  The Vitatron Series 3000 Pacemakers are implantable pulse-generators designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when needed. They are intended for patients with bradycardia (slow heart rate) or other cardiac conduction disorders requiring artificial pacing. Clinicians would recommend these devices for individuals whose natural heart rate is too slow or irregular, helping to maintain a stable and effective heartbeat.

• Are these devices meant for single-use or can they be reused after implantation?

  The Vitatron Series 3000 Pacemakers are explicitly described as intended for single-use implantation within the human body. This means they are not designed for reuse and should be implanted once and then replaced if needed, following standard medical practice for implantable pacemakers.

• How are these pacemakers supplied, and what should I consider when handling them?

  The Vitatron Series 3000 Pacemakers are supplied as sterile implantable medical electronics, ready for direct implantation. Since they are intended for single-use, proper sterile handling and packaging integrity are critical before and during the implantation procedure. The data does not specify additional sterility details, so adherence to general sterile medical device handling protocols is recommended.

• What regulatory pathway was followed for the approval of these pacemakers, and how does that affect their use?

  The Vitatron Series 3000 Pacemakers were cleared through the FDA’s 510(k) process (K760671) and are classified as Class III devices under product code DXY, requiring Premarket Approval. This means they were determined to be substantially equivalent to a legally marketed predicate device and meet stringent safety and effectiveness standards for implantable pacemakers. Clinicians and buyers can rely on this regulatory clearance as assurance of their compliance with FDA requirements.

• Are there multiple models or variations within the Vitatron Series 3000 Pacemakers, and if so, how do I identify the correct one?

  Yes, the Vitatron Series 3000 includes multiple models, each associated with unique registration numbers (e.g., 2017865, 3002807576, etc.). These variations may reflect differences in design or compliance iterations. To ensure the correct model is selected, verify the registration number against the specific device specifications or consult the manufacturer’s documentation, as each model may have subtle differences in functionality or compatibility.