Endocardial Screw-In Lead Model 1020T
by Pacesetter Systems 510(k)
Active
510(k) K895447
Overview
The Endocardial Screw-In Lead Model 1020T is a permanent pacemaker electrode designed for endocardial fixation within the heart. It is classified as a Class III device under FDA regulations and is intended for use in cardiac pacing applications, providing electrical stimulation to regulate heart rhythm through direct myocardial contact.
This lead is supplied sterile and intended for single-use implantation in a clinical setting. It is regulated under FDA 510(k) clearance (K895447) and adheres to the medical specialty of cardiovascular devices. The device is non-MRI compatible and must be handled with sterile techniques prior to use, with storage following manufacturer guidelines to maintain integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895447 | Date20 Dec 1989 | 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- Withdrawn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 Endocardial Screw-In Lead Model 1020T used for in clinical practice?
The Endocardial Screw-In Lead Model 1020T is designed for permanent endocardial fixation within the heart to provide electrical stimulation for cardiac pacing. It ensures direct myocardial contact to regulate heart rhythm in patients requiring chronic pacing support, such as those with bradycardia or conduction system disorders.
Is the Endocardial Screw-In Lead Model 1020T intended for reuse or single-use, and how should it be handled?
This lead is intended for single-use only and must be handled using sterile techniques before implantation. It is supplied sterile, so any unused portion should be discarded according to manufacturer guidelines to maintain sterility and prevent contamination.
What storage instructions should be followed to ensure the device remains intact before use?
The device must be stored following the manufacturer’s guidelines to preserve its integrity. Since it is sterile and intended for single-use, it should be kept in its original packaging until ready for use, protected from moisture, extreme temperatures, and physical damage.
Can this lead be used in patients who require MRI scans, and why?
No, the Endocardial Screw-In Lead Model 1020T is not MRI-compatible. This means it should not be used in patients who require magnetic resonance imaging due to potential risks of device malfunction, heating, or injury from the MRI environment.
How is the regulatory status of this device determined, and what does that mean for purchasing?
The Endocardial Screw-In Lead Model 1020T holds FDA 510(k) clearance (K895447), meaning it has been deemed substantially equivalent to a legally marketed predicate device under FDA regulations. This clearance confirms it meets U.S. safety and performance standards for permanent pacemaker electrodes, ensuring it can be legally purchased and implanted in clinical settings within the U.S.