Lead, Endocardial, Tined, Bipolar, 5MM
by Pacesetter Systems 510(k)
Active
510(k) K801455
Overview
This device is classified as a Permanent Pacemaker Electrode, designed for endocardial placement. It features a tined tip for secure fixation within the heart’s endocardial tissue, with bipolar electrode configuration to facilitate pacing and sensing functions. The 5mm diameter tip ensures precise positioning for reliable cardiac rhythm management.
The lead is intended for single-use in sterile conditions, typically deployed during cardiac procedures such as pacemaker implantation. It adheres to FDA 510(k) clearance under the Traditional pathway, with a Substantially Equivalent decision. Supplied sterile and packaged for clinical use, it is regulated under 870.3680 and falls within Device Class III for cardiovascular applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801455 | Date23 Oct 1980 | 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- Withdrawn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 Pacesetter Systems
Questions
What is the primary purpose of this lead, and how is it secured within the heart?
This lead is designed as a permanent pacemaker electrode for endocardial placement, meaning it is positioned inside the heart’s inner lining to deliver electrical impulses for pacing and sensing cardiac rhythms. The tined tip (a small, barbed structure) provides secure fixation within the endocardial tissue, ensuring stable positioning during long-term use.
Is this lead intended for reuse, or is it meant to be used only once?
This lead is single-use only and must be used in sterile conditions, typically during a cardiac procedure like pacemaker implantation. It is supplied sterile and packaged for one-time clinical deployment, per manufacturer guidelines.
What diameter does the lead’s tip have, and why is this specification important?
The lead features a 5mm diameter tip, which allows for precise positioning within the heart’s endocardial tissue. This size ensures reliable contact for pacing and sensing while minimizing trauma to surrounding tissue during implantation.
How is this lead regulated, and what classification does it fall under?
This lead is classified under Device Class III for cardiovascular applications and is regulated under FDA regulation number 870.3680. It received FDA 510(k) clearance through the Traditional pathway, with a Substantially Equivalent (SESE) decision, indicating it meets performance standards for permanent pacemaker electrodes.