Pacesetter Systems Endocardial Small Fin Lead
by Pacesetter Systems 510(k)
Active
510(k) K854405
Overview
This device is a Permanent Pacemaker Electrode, classified under FDA regulation 870.3680, designed for endocardial placement within the heart. It delivers electrical impulses to regulate cardiac rhythm, ensuring stable pacing performance through its specialized ‘small fin’ design, which minimizes the risk of dislodgement during use.
The Endocardial Small Fin Lead is intended for single-use implantation in cardiac pacemaker systems and has received FDA 510(k) clearance under the Traditional pathway. It is supplied sterile and requires surgical insertion via the venous system into the right atrium or ventricle. The device adheres to Class III regulatory standards and is governed by the Cardiovascular advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854405 | 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- Withdrawn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
- 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 the Pacesetter Systems Endocardial Small Fin Lead, and how does its design help during implantation?
The Pacesetter Systems Endocardial Small Fin Lead is designed to deliver electrical impulses to regulate heart rhythm by pacing the heart muscle. Its ‘small fin’ design minimizes the risk of dislodgement during use, ensuring stable pacing performance after surgical placement in the right atrium or ventricle via the venous system.
Is this lead intended for reuse, or is it meant to be used only once after implantation?
The Pacesetter Systems Endocardial Small Fin Lead is explicitly intended for single-use implantation in cardiac pacemaker systems. It is supplied sterile and should not be reused after surgical placement.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?
This lead received FDA clearance under the Traditional 510(k) pathway, determined to be substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, aligning with its classification as a Class III medical device under FDA regulation 870.3680.
How is the lead supplied, and what precautions should be taken before use?
The lead is supplied sterile and ready for surgical implantation. Since it is intended for single-use, it must be handled in a sterile field during the procedure. Proper aseptic techniques are critical to prevent contamination before and during insertion via the venous system into the heart.