Endocardial Screw-In Lead, Model 1018T
by Pacesetter Systems 510(k)
Active
510(k) K874205
Overview
The Endocardial Screw-In Lead, Model 1018T, is a Permanent Pacemaker Electrode designed for endocardial fixation within the heart. This device is intended for use with implantable pulse generators to facilitate cardiac pacing, ensuring stable electrical contact with the myocardial tissue through a screw-in mechanism for secure anchoring.
This lead is supplied sterile and is intended for single-use implantation in a clinical setting. It is classified as a Class III medical device under FDA regulations (870.3680) and has received FDA 510K clearance as substantially equivalent to a predicate device. The Model 1018T is part of the DTB product code category and is regulated under cardiovascular medical specialty standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874205 | Date2 Feb 1988 | 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- Withdrawn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 Endocardial Screw-In Lead, Model 1018T, and how does it achieve stable electrical contact with heart tissue?
The Endocardial Screw-In Lead, Model 1018T, is designed for permanent cardiac pacing to ensure reliable electrical stimulation of the heart. It achieves stable contact through a screw-in mechanism that anchors the lead securely into the myocardial tissue, providing consistent pacing functionality when used with an implantable pulse generator.
Is the Model 1018T lead intended for reuse after a single implantation, and if not, why?
No, the Model 1018T is explicitly intended for single-use implantation only. This is because it is supplied sterile and designed for one-time clinical use to maintain patient safety and device integrity, preventing potential contamination or degradation from repeated sterilization or reuse.
What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?
The Model 1018T underwent a Traditional 510(k) review process and was deemed substantially equivalent to a predicate device. It was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations (870.3680) for cardiovascular applications.
How is the lead supplied, and what storage considerations should be noted for maintaining its sterility?
The Model 1018T is supplied sterile and packaged for single-use. To preserve sterility, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for expiration dates and handling to ensure optimal performance.