APC Implantable Pacing Lead-Flange #3260

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

510(k) Number

K810397 ↗

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

• 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-Flange #3260 and how does it function within the body?

  The APC Implantable Pacing Lead-Flange #3260 is designed to transmit electrical impulses from an implanted pacemaker to the heart muscle, helping regulate heart rhythm in patients with bradycardia or other cardiac rhythm disorders. It achieves this by delivering precise stimulation to the heart, ensuring consistent and controlled contractions.

• Is this device intended for reuse or single-use, and how is it supplied?

  This device is intended for single-use only and is supplied sterile, ensuring safety and reliability for one-time surgical implantation. It is not designed for reuse, which helps maintain sterility and performance standards.

• What distinguishes the flange design of this pacing lead, and why is it important?

  The flange design of the APC Implantable Pacing Lead-Flange #3260 enhances stability within the heart during implantation. This feature helps secure the lead in place, reducing the risk of displacement and ensuring reliable electrical contact for consistent pacing performance.

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

  The APC Implantable Pacing Lead-Flange #3260 received FDA 510(k) clearance (K810397) under the product code DTB, with a decision of *Substantially Equivalent* to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, allowing it to be legally marketed in the U.S. for cardiovascular applications.

• What types of patients is this lead intended to support, and how does it address their condition?

  This lead is intended for patients with bradycardia or other rhythm disorders requiring cardiac pacing. By delivering regulated electrical impulses to the heart muscle, it helps maintain a consistent and healthy heart rate, improving overall cardiac function and quality of life for these patients.