Modified Multicor and Omni-Stanicor Pacemakers

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

510(k) Number

K873158 ↗

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 Ancor Hi-Flex Unipolar Active Fix Lead

  Class III

  FDA 510(k) K885240 Active Cleared 10 Feb 1989

• Multicor Pacemakers

  Class III

  FDA 510(k) K880898 Active Cleared 6 May 1988

• Are these pacemakers designed for reuse or are they intended to be used only once after opening?

  These Modified Multicor and Omni-Stanicor Pacemakers are supplied as sterile, single-use devices. They are intended for surgical implantation and should not be reused after opening to maintain sterility and ensure patient safety.

• What types of storage conditions should be followed for these pacemakers to ensure their integrity?

  Since these devices are sterile, they must be stored and handled according to sterile medical device protocols. This includes keeping them in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.

• How many model variants of these pacemakers are available, and how are they differentiated?

  Multiple model variants exist for these pacemakers, each listed under specific registration numbers such as 2017865, 3005334138, and others. While the exact specifications for differentiation (e.g., pacing capabilities, battery life, or lead configurations) are not detailed here, the variety ensures compliance with cardiovascular medical specialty requirements and regulatory coverage under 870.3610.

• What regulatory pathway was followed for FDA clearance of these pacemakers, and which advisory committee was involved?

  These devices were cleared through the FDA’s 510(k) pathway under the traditional review process, with a decision code of SESE (Substantially Equivalent). The Cardiovascular (CV) advisory committee was involved in the review process, as indicated by the advisory committee description and review panel records.

• What is the primary clinical purpose of these pacemakers, and what conditions do they address?

  These pacemakers are designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm. They are intended for patients with bradycardia or conduction disorders, helping to support cardiac function by ensuring proper heart pacing.