Endocard Pacin Lead-Std Length PL100

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771564 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Adapter Kit

  Class II

  FDA 510(k) K781864 Active Cleared 19 Dec 1978

• Pacemaker, Perm. & Temp., Electrode

  Class III

  FDA 510(k) K772197 Active Cleared 30 Jan 1978

• Permanent Lead Intraducer

  Class II

  FDA 510(k) K800356 Active Cleared 28 May 1980

• Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K800352 Active Cleared 28 May 1980

• Daig Pacel(Tm) Flow Directed Pacing Catheter

  Class II

  FDA 510(k) K890794 Active Cleared 20 Jun 1989

• Unipolar Lead Configuration Conductor

  Class III

  FDA 510(k) K800348 Active Cleared 28 May 1980

See all devices from Daig Corp. →

• What is the primary purpose of the ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100 device, and how does it function in a clinical setting?

  The ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100 is a permanent pacemaker electrode designed for endocardial pacing, meaning it delivers electrical impulses directly to the heart muscle to maintain a proper heart rhythm. It is used in patients with bradycardia (slow heart rate) or conduction disorders, ensuring consistent pacing signals to regulate cardiac function. The lead is implanted during cardiac electrophysiology procedures and works in conjunction with a pacemaker to stimulate the heart when natural electrical signals are insufficient.

• Is this device intended for reuse, or is it meant to be used only once after implantation?

  This device is sterile and intended for single-use only. It is not designed for reuse, and proper sterile medical device protocols must be followed during handling and implantation to ensure patient safety.

• What storage and handling precautions should be taken with the ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100?

  Since this is a sterile, single-use device, it must be stored and handled according to sterile medical device protocols to prevent contamination. The packaging should remain intact until use, and any exposure to non-sterile environments should be avoided. Follow manufacturer guidelines for shelf life and storage conditions to maintain device integrity.

• Does this device comply with MRI safety guidelines, and how should it be considered in a clinical setting involving magnetic resonance imaging?

  Yes, this device adheres to MRI safety guidelines for pacemaker electrodes, meaning it is designed with considerations for compatibility with MRI procedures. However, clinical protocols must still be followed carefully, as MRI use with pacemaker leads carries risks. Always consult the manufacturer’s instructions and local MRI safety guidelines before exposing the patient to MRI environments.

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

  This device was cleared through the FDA’s 510(k) pathway, specifically a Traditional 510(k) submission, and is classified as a Class III medical device. This means it underwent a rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to demonstrate substantial equivalence to a legally marketed predicate device. Clinically, this indicates that the device has met FDA standards for safety and effectiveness, but practitioners should always refer to the latest labeling and guidelines for proper use.