Unifocal 3

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

510(k) Number

K810121 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Apc Implantabel Pacing Lead, Model 3264

  Class III

  FDA 510(k) K810399 Active Cleared 15 May 1981

• APC Implantable Pacing Lead, Tined #3262

  Class III

  FDA 510(k) K810396 Active Cleared 15 May 1981

• Unifocal 1 Unipolar Demand R Wave

  Class III

  FDA 510(k) K791955 Active Cleared 27 Nov 1979

• APC Implantable Pacing Lead-Flange #3260

  Class III

  FDA 510(k) K810397 Active Cleared 15 May 1981

• External Pulse Generator EV4542

  Class II

  FDA 510(k) K821791 Active Cleared 6 Jul 1982

• Unifocal 2-UNIPOLAR & Bipolar

  Class III

  FDA 510(k) K792199 Active Cleared 27 Nov 1979

See all devices from American Pacemaker Corp. →

• What is the primary purpose of the Unifocal 3 pacemaker, and how does it address heart rhythm issues?

  The Unifocal 3 is designed to regulate heart rhythm by delivering controlled electrical impulses to the heart muscle when the natural conduction system fails. It is specifically intended for patients with bradycardia or conduction disorders, ensuring consistent cardiac function by compensating for slow or irregular heartbeats.

• Is the Unifocal 3 meant for single-use or can it be reused after implantation?

  The Unifocal 3 is supplied as a reusable, implantable pulse-generator. While it is intended for permanent implantation, it requires sterile handling prior to use, as it is not designed for repeated external use or non-sterile reuse.

• What regulatory pathway was followed for the FDA clearance of the Unifocal 3, and what does that mean for its safety standards?

  The Unifocal 3 received FDA 510(k) clearance under the product code DXY, classified as a Class III device, which is the highest risk category for medical devices. This clearance was determined through a traditional review process by the FDA’s Cardiovascular (CV) advisory committee, ensuring it meets stringent regulatory standards for life-sustaining or life-supporting devices, as outlined in regulation number 870.3610.

• How is the Unifocal 3 intended to be used in clinical settings, and what type of patients is it typically prescribed for?

  The Unifocal 3 is intended for use in cardiovascular settings, specifically for patients with bradycardia or conduction disorders where the heart’s natural pacemaker is insufficient. It is implanted surgically to provide consistent electrical stimulation to maintain proper heart rhythm, making it suitable for patients requiring long-term cardiac support.