Pacepath Implantable Endocard. Pacing Ld

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K811200 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K821547 Active Cleared 2 Jun 1982

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• What types of arrhythmias is this device designed to treat, and how does it work within the heart?

  The Pacepath Implantable Endocardial Pacing Lead is designed for endocardial pacing, meaning it regulates cardiac rhythm by delivering electrical impulses directly to the inner lining of the heart chambers. It is intended for patients with arrhythmias—specifically, those requiring precise pacing to correct abnormal heartbeats. The lead’s flexible, insulated conductors and tined tip allow for accurate placement within the heart, ensuring stable contact to maintain consistent pacing.

• Is this device reusable, or is it intended for single-use only after implantation?

  This device is intended for single-use only. Once implanted by a cardiologist in a clinical setting, it is not designed for removal or reuse. The lead is supplied sterile and is meant to remain permanently in place to provide long-term pacing support.

• What storage conditions are recommended for this device before implantation?

  Since the Pacepath Implantable Endocardial Pacing Lead is supplied sterile, it should be stored in its original packaging under clean, dry conditions away from direct sunlight or extreme temperatures. The manufacturer’s packaging instructions (not provided here) should be followed to maintain sterility until use.

• Are there multiple sizes or models available, and how would I identify the correct one for a patient?

  Yes, this device comes in multiple model variants, each identified by unique registration numbers (e.g., 2017865, 3002618605). The correct model depends on clinical factors like the patient’s anatomy, pacing requirements, and the cardiologist’s preference. Consult the manufacturer’s documentation or a medical device specialist to match the appropriate model to the patient’s needs.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  The Pacepath Implantable Endocardial Pacing Lead received FDA 510(k) clearance in 1981 (K811200), demonstrating it was deemed substantially equivalent to a legally marketed device at the time. This clearance was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee under the traditional 510(k) pathway. Clinically, this means the device is legally marketed for its intended use—permanent endocardial pacing—and must be implanted by qualified cardiologists in a controlled clinical setting.