APC Implantable Pacing Lead

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

510(k) Number

K812830 ↗

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. →

• What is the primary purpose of the APC Implantable Pacing Lead, and how does it function in the body?

  The APC Implantable Pacing Lead is designed to deliver electrical stimulation to the heart muscle, helping regulate abnormal heart rhythms (arrhythmias) in patients who require cardiac pacing support. It connects to a pacemaker generator via a flexible, insulated wire, ensuring proper electrical conduction to maintain consistent heart function.

• Is the APC Implantable Pacing Lead intended for reuse, or is it meant to be used only once?

  The device is explicitly intended for single-use implantation within the cardiovascular system. It is supplied sterile to ensure safety and efficacy during one-time use only, adhering to medical best practices for implantable leads.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The APC Implantable Pacing Lead received FDA 510(k) clearance (K812830) under a *Substantially Equivalent (SESE)* decision, meaning it was determined to be as safe and effective as a legally marketed device already on the market. This clearance was granted by the FDA’s Cardiovascular (CV) advisory committee, ensuring compliance with regulatory standards for permanent pacemaker electrodes.

• How should the APC Implantable Pacing Lead be stored before use, and are there any special handling requirements?

  While the device is supplied sterile, specific storage instructions are not detailed in the provided data. Generally, implantable leads should be stored in a clean, dry environment, protected from moisture and extreme temperatures, until ready for use. Always follow manufacturer guidelines or packaging labels for precise storage protocols.