Endocard. Pacing Lead-Long Length PL203
by Daig Corp. 510(k)
Active
510(k) K771567
Overview
This device is an endocardial pacing lead, a component of a permanent pacemaker system designed to deliver electrical impulses to the heart’s endocardium. It facilitates cardiac rhythm regulation by transmitting pacing signals through its conductive tip, ensuring proper synchronization of heart contractions in patients with bradycardia or conduction disorders.
The lead is supplied sterile and intended for single-use implantation via venous access, typically positioned within the right atrium or ventricle. It is classified as a Class III device under FDA regulations and requires professional medical placement by a trained clinician. The PL203 model features a long length for specific anatomical applications, adhering to FDA 510(k) clearance (K771567) for permanent pacemaker electrodes.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771567 | Date14 Sep 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Daig Corp.
Questions
What is the primary purpose of the ENDOCARD. PACING LEAD-LONG LENGTH PL203 in a patient’s treatment plan?
The ENDOCARD. PACING LEAD-LONG LENGTH PL203 is designed to deliver electrical impulses to the heart’s endocardium, helping regulate cardiac rhythm in patients with bradycardia or conduction disorders. It is a component of a permanent pacemaker system, ensuring synchronized heart contractions by transmitting pacing signals through its conductive tip.
Is this device intended for reuse, or is it meant to be used only once after implantation?
This device is explicitly intended for single-use after implantation. It is supplied sterile and must be discarded following a single procedure to maintain safety and efficacy, as per its design specifications.
What anatomical areas is the PL203 model specifically designed to target during implantation?
The PL203 model features a long length, making it suitable for positioning within the right atrium or ventricle of the heart. Its design accommodates specific anatomical requirements for endocardial pacing leads in permanent pacemaker systems.
How is the sterility of the ENDOCARD. PACING LEAD-LONG LENGTH PL203 ensured before use?
The device is supplied sterile by the manufacturer, Daig Corp., ensuring it is ready for immediate use in a clinical setting without additional sterilization steps. This is critical for single-use medical devices to prevent infection risk during implantation.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?
The ENDOCARD. PACING LEAD-LONG LENGTH PL203 underwent a Traditional 510(k) review through the FDA’s Cardiovascular (CV) advisory committee, with a decision of Substantially Equivalent (SESE). This means it was determined to have the same intended use and technological characteristics as a legally marketed predicate device, ensuring its safety and effectiveness for endocardial pacing applications.