APC Implantable Pacing Lead, Tined #3262

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

510(k) Number

K810396 ↗

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

• Unifocal 1 Unipolar Demand R Wave

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  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, Tined #3262, and how does its design support its function?

  The APC Implantable Pacing Lead, Tined #3262 is designed to deliver electrical impulses to the heart muscle, helping maintain proper heart rhythm in patients with bradycardia or conduction disorders. The tined design enhances fixation within the cardiac chamber, ensuring stable lead positioning during and after implantation. This stability is critical for reliable pacing performance over time.

• Is this device intended for reuse, or is it meant for single-use only? How should it be handled before implantation?

  This device is supplied sterile and intended for single-use only during surgical procedures. Due to its sterile packaging and classification as a Class III medical device, it must be handled under aseptic conditions to prevent contamination before implantation. Reuse is not recommended or supported by the manufacturer.

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

  The APC Implantable Pacing Lead, Tined #3262 was cleared via the FDA 510(k) pathway, specifically under Traditional Review by the Cardiovascular (CV) Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for use in cardiac electrophysiology settings. Clinicians can rely on this clearance as evidence of regulatory scrutiny before implementation.

• Where is this device manufactured, and what address should be referenced for regulatory or distribution inquiries?

  The device is manufactured by American Pacemaker Corp. at their facility located at 803 N. Front St. Suite 3, Mchenry, IL 60050. This address is relevant for regulatory inquiries, distribution requests, or compliance-related communications, as it is the official address listed in the FDA submission records.

• How does the tined design of this lead differ from other pacing leads, and what clinical benefits does it provide?

  The tined design of the APC Implantable Pacing Lead, Tined #3262 features small, flexible protrusions at the distal end that anchor the lead to the cardiac chamber wall. This contrasts with smooth-tip leads, which rely on passive fixation or passive fixation tines. The tined design provides enhanced stability and reduced risk of dislodgment, which is particularly beneficial for patients with irregular heart rhythms or those requiring long-term pacing support. This stability ensures consistent electrical stimulation and reduces the need for frequent lead adjustments.