Endocar Pacing Lead-Std Length PL202

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771566 ↗

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 Endocar Pacing Lead-Std Length PL202 used for in clinical practice?

  The Endocar Pacing Lead-Std Length PL202 is designed for endocardial pacing, meaning it delivers electrical impulses directly to the heart’s chambers to correct abnormal heart rhythms (arrhythmias) or conduction disorders. It connects to an external pacemaker system and is implanted within the heart to help regulate cardiac function in patients requiring chronic pacing support.

• Is this device intended for single-use or can it be reused?

  The Endocar Pacing Lead-Std Length PL202 is supplied sterile and intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

• What length configuration does this pacing lead have, and does it come in multiple sizes?

  This specific model, the PL202, is described as having a standard length configuration for endocardial pacing. While the data does not list multiple sizes, the product code (DTB) and classification as a permanent pacemaker electrode suggest it is tailored for typical endocardial implantation needs. For exact sizing options, consulting the manufacturer’s catalog or technical specifications is advised.

• How is the device regulated in the U.S., and what does the FDA clearance indicate?

  The Endocar Pacing Lead-Std Length PL202 holds an FDA 510(k) clearance (K771566), meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance was granted under the Cardiovascular (CV) advisory committee and follows a traditional review process. It adheres to regulatory standards for Class 3 cardiovascular implants, ensuring compliance with safety and performance requirements for permanent pacemaker electrodes.

• How should the device be stored before use, given it is sterile?

  Since the Endocar Pacing Lead-Std Length PL202 is supplied sterile, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to maintain sterility. Always follow the manufacturer’s specific storage instructions provided in the accompanying documentation.