Vicor Pacer Model 410A

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

510(k) Number

K880432 ↗

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 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

• Multicor Pacemakers

  Class III

  FDA 510(k) K880898 Active Cleared 6 May 1988

• What types of patients is the Vicor Pacer Model 410A intended to treat, and how does it work?

  The Vicor Pacer Model 410A is designed for patients with bradycardia or other cardiac conduction disorders that require artificial pacing. It regulates heart rhythm by delivering electrical impulses to the heart muscle when the natural heartbeat is too slow or irregular. The device is implanted subcutaneously in the chest and connected to leads placed within the heart chambers to ensure proper pacing.

• Is the Vicor Pacer Model 410A a single-use or reusable device, and what are the handling requirements during implantation?

  The Vicor Pacer Model 410A is a reusable device intended for long-term use. Since it is implanted subcutaneously, it must be handled under sterile conditions during the implantation procedure to prevent infection and ensure patient safety.

• Can this device be used safely in an MRI environment, and what should clinicians confirm before proceeding?

  The Vicor Pacer Model 410A operates within MRI-safe parameters as defined by its specifications. However, clinicians should confirm specific MRI compatibility details with the manufacturer before any MRI procedure, as individual patient cases and settings may vary.

• What regulatory pathway was followed for market authorization of the Vicor Pacer Model 410A in the United States?

  The Vicor Pacer Model 410A was authorized for use in the United States through an FDA 510(k) clearance process, specifically under clearance number K880432. This device falls under Class III regulatory classification, requiring a Premarket Approval (PMA) or 510(k) clearance for market authorization.