Unifocal VP, Models 7501 and 7502

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

510(k) Number

K800746 ↗

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 clinical purpose of the Unifocal VP, Models 7501 and 7502, and how does it achieve this?

  The Unifocal VP, Models 7501 and 7502, are implantable pacemaker pulse-generators designed to regulate cardiac rhythm in patients with bradycardia or conduction system disorders. They achieve this by delivering electrical stimulation to the heart, ensuring appropriate heart rates and synchronized contractions to maintain effective cardiac function.

• Are the Unifocal VP, Models 7501 and 7502, intended for single-use or reusable applications, and how should they be handled?

  The Unifocal VP, Models 7501 and 7502, are supplied sterile for single-use only. Due to their sterile packaging and intended surgical implantation, they must be handled according to strict sterile medical device protocols to prevent contamination.

• What regulatory pathway was followed for the clearance of the Unifocal VP, Models 7501 and 7502, and what does this imply about their classification?

  The Unifocal VP, Models 7501 and 7502, were cleared via a Traditional 510(k) pathway under FDA regulation number 870.3610, with a decision date of December 16, 1980. They are classified as Class III devices, which is the highest risk classification for medical devices, indicating they require stringent regulatory oversight.

• What types of procedures are these devices intended for, and how should they be stored?

  The Unifocal VP, Models 7501 and 7502, are intended for use in cardiovascular procedures specifically for surgical implantation as pacemaker pulse-generators. While the data does not specify storage conditions, as a sterile, single-use implantable device, they should be stored in a clean, dry environment, protected from physical damage and contamination, following the manufacturer’s guidelines.