Endocardial Screw-in Lead Model 1028T
by Pacesetter Systems 510(k)
Active
510(k) K902147
Overview
The Endocardial Screw-in Lead Model 1028T is a Permanent Pacemaker Electrode, classified under FDA regulation 870.3680. This device is designed for endocardial implantation, providing electrical stimulation to the heart muscle to regulate cardiac rhythm in patients with bradycardia or conduction disorders. Its screw-in mechanism ensures secure fixation within the cardiac tissue, ensuring stable pacing functionality.
This lead is intended for single-use implantation in cardiac electrophysiology procedures. Supplied sterile and intended for use in Class III medical devices, it adheres to FDA 510(k) clearance (K902147) under the Traditional review pathway. The device is categorized under the DTB product code and is regulated within the cardiovascular specialty. No additional storage or handling specifications are noted beyond standard sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902147 | Date17 Jul 1990 | 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- Withdrawn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 1028T and how does its design support that purpose?
The Endocardial Screw-in Lead Model 1028T is designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders by delivering electrical stimulation to the heart muscle. Its screw-in mechanism ensures secure fixation within the cardiac tissue, providing stable pacing functionality during implantation.
Is this device intended for reuse or single-use, and what does that mean for clinical workflows?
This device is explicitly intended for single-use implantation in cardiac electrophysiology procedures. This means each lead is sterile upon packaging and should not be reused, ensuring patient safety and compliance with sterile medical device protocols.
What regulatory pathway was followed for FDA clearance of this device, and what does that imply for its safety and efficacy?
The Endocardial Screw-in Lead Model 1028T was cleared via the FDA 510(k) Traditional review pathway under clearance number K902147, with a decision of Substantially Equivalent (SESE). This implies the device was evaluated against a legally marketed predicate and deemed comparable in safety and effectiveness, adhering to strict cardiovascular device regulations (FDA regulation 870.3680).
Are there any special storage requirements for this lead beyond standard sterile medical device protocols?
No additional storage or handling specifications are noted beyond standard sterile medical device protocols. The lead is supplied sterile, so it should be stored in its original packaging until ready for use, following general aseptic techniques for implantable devices.
How is this device categorized in terms of medical specialty and regulatory classification?
The Endocardial Screw-in Lead Model 1028T falls under the cardiovascular specialty and is classified as a Class III medical device by the FDA. It is regulated under product code DTB and is intended for permanent pacemaker electrode applications, requiring compliance with stringent cardiovascular device standards.