APC Implantable Pacing Leads

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

510(k) Number

K812807 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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. →

• Are these pacing leads designed for reuse or are they single-use only, and how should they be handled to maintain sterility?

  The APC Implantable Pacing Leads are explicitly intended for single-use only after implantation. Since they are supplied sterile, proper sterile handling protocols must be followed during storage, preparation, and implantation to prevent contamination. Once used, they should be discarded according to medical device disposal guidelines.

• What types of pacemaker systems are these leads compatible with, and how do I identify the correct model for my patient?

  These leads are designed for compatibility with multiple pacemaker systems and come in various model references, including 3002618605, 1028232, and others. The correct model depends on the specific pacemaker device being used. Always verify compatibility with your chosen pacemaker system’s documentation or consult the manufacturer’s guidelines to ensure proper pairing.

• How should these leads be stored to ensure they remain sterile and functional until use?

  Since these leads are sterile upon supply, they must be stored in their original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Follow the manufacturer’s storage instructions to maintain sterility and integrity until implantation. Avoid exposing them to moisture or contamination.

• What regulatory pathway does this device follow, and how does that affect its use in clinical settings?

  The APC Implantable Pacing Leads are regulated under FDA 510(k) clearance (K812807), classified as Class III (DTB) for pacemaker electrodes. This means they undergo rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness. Clinicians can rely on this clearance as evidence of regulatory compliance, though local hospital protocols and physician discretion should still guide their use.