Pacing Leads Model UL-811 and UL-813
by Pacesetter Systems 510(k)
Active
510(k) K781776
Overview
The Pacing Leads Model UL-811 and UL-813 are Permanent Pacemaker Electrodes, designed to deliver electrical impulses to the heart for cardiac pacing. These leads facilitate proper heart rhythm by transmitting pacing signals to the myocardium, ensuring effective cardiac conduction in patients requiring chronic pacing support.
These leads are intended for single-use implantation and are classified as Class III medical devices under FDA regulations (870.3680). Supplied sterile, they are regulated through the FDA’s 510(k) pathway and are distributed with the product code DTB. No additional context regarding MRI safety, reusable components, or alternative sterilisation methods is provided in the submitted data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781776 | Date27 Oct 1978 | 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- Withdrawn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
Are these pacing leads designed for reuse or are they intended for single-use only? Why does that matter?
These leads (UL-811 and UL-813) are explicitly intended for single-use implantation only, as stated in the device description. This matters because single-use devices reduce the risk of cross-contamination and infection, which is critical in cardiac procedures where sterility is paramount. Reusing medical electrodes, especially those implanted in the heart, poses significant safety risks due to potential material degradation, sterility compromise, or mechanical failure over time.
How are these leads supplied, and what does the sterility guarantee mean for clinical workflows?
The leads are supplied sterile as part of their packaging, which means they are pre-sterilized and ready for immediate use without additional processing. This ensures that the leads meet rigorous infection control standards before implantation, streamlining the clinical workflow by eliminating the need for on-site sterilization or cleaning. Sterility is particularly important for cardiac devices to prevent postoperative infections, which can be life-threatening in patients with compromised cardiac function.
What regulatory pathway was used to clear these leads, and how does that affect their use in clinical practice?
These leads were cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process with a decision labeled as *Substantially Equivalent* (SESE). This means the manufacturer demonstrated that the leads are as safe and effective as a legally marketed predicate device already on the market. Clinically, this clearance indicates that the leads have undergone rigorous evaluation for safety and performance, but it does not imply they are approved for all patients—only that they meet FDA standards for chronic cardiac pacing when used as intended.
Are there multiple sizes or models available for these leads, and if so, how might a clinician determine the right fit for a patient?
The data provided does not specify distinct sizes or models beyond the two listed (UL-811 and UL-813), but the product code DTB (Permanent Pacemaker Electrodes) suggests these are designed for general cardiac pacing applications. Clinicians typically select leads based on patient anatomy, pacing requirements (e.g., atrial vs. ventricular pacing), and the specific pacemaker system being used. The manufacturer’s documentation (not provided here) would detail compatibility with different pacing systems, electrode tip configurations, and lead lengths to ensure proper placement and function.