Pacesetter Systems Endocardial Tri-Fix Lead
by Pacesetter Systems 510(k)
Active
510(k) K854220
Overview
This device is an Endocardial Electrode, designed for permanent pacemaker implantation to stimulate the heart muscle. It features a Tri-Fix fixation mechanism to secure the lead within the endocardial tissue, ensuring stable electrical contact for consistent pacing therapy.
The Endocardial Tri-Fix Lead is intended for single-use in cardiac electrophysiology procedures. Supplied sterile and packaged for surgical use, it adheres to FDA 510(k) clearance under the Traditional review pathway (K854220). Compatible with permanent pacemaker systems, it is classified as a Class III device under the Device Type: Permanent Pacemaker Electrode nomenclature.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854220 | Date4 Dec 1985 | 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- Withdrawn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
- Full name
- Pacesetter Sysems Endocardial Tri-Fix Lead
- 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