Multicor Pacemakers

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Multicor and Pacemakers

510(k) Number

K880898 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 255A Programmer III, W/Software Revi. 4004

  Class III

  FDA 510(k) K882429 Active Cleared 22 Jul 1988

• Vicor Pacer Model 410A

  Class III

  FDA 510(k) K880432 Active Cleared 22 Feb 1988

• Vicor Model 410A Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K873202 Active Cleared 15 Oct 1987

• Modified Multicor and Omni-Stanicor Pacemakers

  Class III

  FDA 510(k) K873158 Active Cleared 7 Jan 1988

• Modified Ancor Hi-Flex Unipolar Active Fix Lead

  Class III

  FDA 510(k) K885240 Active Cleared 10 Feb 1989

• Are the Multicor Pacemakers designed for reuse or are they intended as single-use devices?

  The Multicor Pacemakers are supplied as sterile, single-use components. They are intended for surgical implantation and are not designed for reuse, ensuring patient safety and compliance with medical device standards.

• What types of heart conditions are these pacemakers intended to address?

  These devices are specifically designed to regulate heart rhythm by delivering electrical impulses to address bradycardia or other conduction disorders, ensuring proper cardiac function in patients with abnormal heart rhythms.

• How are the Multicor Pacemakers classified under FDA regulations, and what does this mean for their use?

  The Multicor Pacemakers are classified as Implantable Pacemaker Pulse-Generators under FDA 510(k) clearance with a decision classification of *Substantially Equivalent*. This means they meet regulatory standards comparable to previously approved devices, ensuring their safety and effectiveness for surgical implantation in cardiovascular settings.

• What storage requirements or handling considerations apply to these pacemakers before implantation?

  Since the Multicor Pacemakers are supplied as sterile, single-use components, they must be stored in their original packaging to maintain sterility until use. Proper handling and storage conditions are critical to preserve their integrity before surgical implantation.

• How can I verify the specific model or variant of a Multicor Pacemaker, and why does this matter?

  Each Multicor Pacemaker variant is tracked using unique FEI numbers (e.g., 3002807576, 2017865, etc.), which correspond to specific models listed under product code DXY. This identification helps ensure the correct device is selected for a patient’s needs and facilitates regulatory compliance during use.