Apc Implantabel Pacing Lead, Model 3264

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

510(k) Number

K810399 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• APC Implantable Pacing Lead, Model 3266

  Class III

  FDA 510(k) K810398 Active Cleared 15 May 1981

See all devices from American Pacemaker Corp. →

• What is the primary purpose of the APC Implantable Pacing Lead, Model 3264, and how does it function in the body?

  The APC Implantable Pacing Lead, Model 3264, is designed to transmit electrical impulses from an implanted pacemaker to the heart muscle, helping regulate heart rhythm. It is inserted transvenously and positioned within the heart to deliver timed electrical stimulation, ensuring proper cardiac function in patients with bradycardia (slow heart rate) or conduction disorders. This lead is part of a cardiac pacing system and facilitates precise rhythm management.

• Is the APC Implantable Pacing Lead, Model 3264, intended for single-use or can it be reused?

  The APC Implantable Pacing Lead, Model 3264, is supplied sterile and intended for single-use only. This ensures patient safety and sterility during implantation, as reusing medical devices like this can introduce risks of infection or device malfunction.

• What regulatory pathway was followed for the FDA clearance of this device, and what classification does it fall under?

  The APC Implantable Pacing Lead, Model 3264, received FDA clearance through a 510(k) submission with a Substantially Equivalent (SESE) decision, meaning it was deemed comparable to a legally marketed predicate device. It is classified as a Class III device under 21 CFR 870.3680, reflecting its role in life-sustaining or life-supporting functions, and it adheres to cardiovascular medical specialty standards.

• How is the device supplied, and what should clinicians consider when handling or storing it?

  The APC Implantable Pacing Lead, Model 3264, is supplied sterile and packaged for single-use. Clinicians should ensure the packaging remains unopened and intact until immediate use to maintain sterility. Storage should follow manufacturer guidelines to preserve the device’s integrity, typically in a clean, dry environment away from direct sunlight or extreme temperatures.

• What advisory committee reviewed this device during its regulatory submission, and what does that indicate about its intended use?

  The device was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates cardiovascular medical devices. This indicates the lead’s intended use is within the cardiovascular specialty, specifically for precise cardiac rhythm management in clinical settings requiring reliable pacing solutions.