Vicor Model 410A Implantable Pacemaker Pulse-Generator

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

Full name

Vicor, Model 410A

510(k) Number

K873202 ↗

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

• 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

• Multicor Pacemakers

  Class III

  FDA 510(k) K880898 Active Cleared 6 May 1988

• What is the primary purpose of the Vicor Model 410A pacemaker, and how does it function in the body?

  The Vicor Model 410A is an implantable pacemaker pulse-generator designed to regulate heart rhythm by delivering controlled electrical pulses to the heart. It is surgically implanted and uses its internal power supply and electronic circuits to stimulate cardiac contraction when the patient’s natural rhythm is insufficient, ensuring proper pacing support for patients requiring it.

• Is the Vicor Model 410A intended for reuse, or is it meant to be used only once after implantation?

  The Vicor Model 410A is supplied sterile and explicitly intended for single-use only. Once implanted, it is not designed for removal or reuse, aligning with standard practices for implantable cardiac devices to maintain patient safety and sterility.

• What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?

  The Vicor Model 410A received FDA clearance through a Traditional 510(k) process (K873202), determined to be *substantially equivalent* to a predicate device. The review was conducted under the Cardiovascular Device Advisory Committee (CV), reflecting its classification as a Class III device under FDA regulations.

• How is the device packaged and stored before use, and are there any special handling requirements?

  The Vicor Model 410A is supplied sterile and packaged for surgical implantation. While specific storage instructions aren’t detailed in the data, standard practices for implantable devices—such as protecting from moisture, extreme temperatures, and physical damage—should be followed. Always refer to the manufacturer’s included instructions for precise handling.