APC Implantable Pacing Lead, Model 3266

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

510(k) Number

K810398 ↗

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, Model 3266, and how does it function in the body?

  The APC Implantable Pacing Lead, Model 3266, is designed to transmit electrical impulses from an implanted pacemaker to the heart muscle. Its primary purpose is to regulate cardiac rhythm by stimulating the heart chambers when needed, ensuring proper heart function in patients with pacing requirements.

• Is the APC Implantable Pacing Lead, Model 3266, intended for single-use or can it be reused after implantation?

  The device is supplied sterile and explicitly intended for single-use only. It is not designed or approved for reuse, as this could compromise patient safety and sterility.

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

  The APC Implantable Pacing Lead, Model 3266, was cleared through the FDA’s 510(k) pathway as substantially equivalent (SESE) in 1981. This means the device was determined to have the same intended use, technological characteristics, and performance as a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in cardiac pacing applications.

• What are the key specifications or product codes associated with this device that help identify its regulatory classification?

  The device is classified under FDA product code DTB and falls under regulation number 870.3680, categorized as a Class III device. It is also associated with multiple registration numbers (e.g., 2017865, 2032521) and is regulated under the Cardiovascular medical specialty, reflecting its use in pacing applications.

• How should the APC Implantable Pacing Lead, Model 3266, be stored before use, given its sterile packaging?

  Since the device is supplied sterile for single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for storage to maintain sterility and integrity until implantation.