Vicor Models 410B, 410D, and Modified 410A Pacemaker

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

Full name

Vicor Models 410B & 410D and Modified 410A Pacema.

510(k) Number

K881711 ↗

FDA Product Code

DXY

Models / Variants

410B

410D

Modified 410A Pacema.

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 329-701 Bipolar Active-Fixation Lead

  Class III

  FDA 510(k) K883265 Active Cleared 14 Oct 1988

• Cathode Powder Specification Change

  Class III

  FDA 510(k) K881904 Active Cleared 22 Jul 1988

• Are these pacemakers designed for reuse or are they single-use devices intended for one-time implantation?

  The Vicor Models 410B, 410D, and Modified 410A are explicitly designed for single-use implantation only. The device description confirms they are not intended for reuse, aligning with standard practices for implantable pulse generators to ensure patient safety and sterility.

• What specific cardiac rhythm disorders are these pacemakers intended to manage, and how do they function?

  These pacemakers are intended to manage cardiac rhythm disorders, including both intermittent and continuous abnormalities, by serving as a substitute for the heart’s intrinsic pacing system. They generate periodic electrical pulses to regulate heartbeats when the natural conduction system fails, ensuring proper cardiac rhythm.

• How are these devices supplied, and what should clinicians consider regarding their handling before implantation?

  The Vicor Models 410B, 410D, and Modified 410A are implantable pulse generators supplied as sterile devices for surgical implantation. While the data does not specify explicit sterility assurances (e.g., terminal sterilization method), they are governed by cardiovascular regulatory standards, implying adherence to industry best practices for sterility and handling. Clinicians should follow standard aseptic techniques during implantation.

• What distinguishes the Vicor Models 410B, 410D, and Modified 410A from each other, and how are they identified?

  The models are differentiated by their unique reference codes: 410B, 410D, and Modified 410A. These distinctions likely reflect variations in specifications (e.g., pacing modes, battery life, or programming features), though the provided data does not detail these differences. They are all registered under multiple FDA registration numbers, confirming their individual regulatory tracking.

• What regulatory pathway was followed for FDA clearance of these devices, and what does this imply for their safety and efficacy?

  These pacemakers were cleared via the FDA 510(k) pathway (K881711), classified under device class III (870.3610) and reviewed by the Cardiovascular (CV) Advisory Committee. The decision was marked as *Substantially Equivalent (SESE)*, meaning they were deemed comparable to legally marketed devices in terms of safety and effectiveness. This pathway ensures rigorous evaluation of implantable cardiac devices.