Additional Cardiac Pacing Leads #1020 Through 1035
by Pacesetter Systems 510(k)
Active
510(k) K870824
Overview
These devices are Permanent Pacemaker Electrodes, designed to provide electrical stimulation for cardiac pacing. They are intended for implantation within the heart to regulate abnormal heart rhythms by delivering timed electrical impulses through the pacing lead system.
The leads are supplied sterile and intended for single-use implantation in a clinical setting. They are classified as Class III devices under FDA regulation (870.3680) and were cleared via a Traditional 510(k) pathway (K870824) in 1987. Each model number (#1020 through #1035) corresponds to a specific electrode configuration for compatibility with pacemaker systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870824 | Date20 Mar 1987 | 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- Withdrawn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 reusable in a clinical setting, or are they intended for single-use only?
These leads are explicitly designed for single-use implantation after sterile packaging. The manufacturer’s description and FDA clearance specify they are supplied sterile and intended for one-time use in patients, ensuring patient safety and reducing infection risks.
What types of pacemaker systems are these leads compatible with, and how do I determine the correct model for my patient?
Each model (#1020 through #1035) is engineered for specific electrode configurations to match compatible pacemaker systems. The model number corresponds directly to the lead’s design—verify compatibility with your pacemaker’s technical specifications or consult the manufacturer’s documentation to select the correct lead for your patient’s needs.
How should these leads be stored before use, and is there any special handling required?
Since these leads are sterile upon packaging, they should be stored in their original, unopened packaging to maintain sterility. Avoid exposure to moisture, extreme temperatures, or physical damage. Follow the manufacturer’s instructions for shelf-life and storage conditions to ensure optimal performance and safety.
What regulatory pathway was used for FDA clearance, and what does that mean for clinical use?
These leads were cleared via a Traditional 510(k) pathway (K870824) under FDA’s Class III designation (870.3680), meaning they were deemed substantially equivalent to a legally marketed predicate device. This clearance ensures they meet FDA safety and effectiveness standards for permanent cardiac pacing applications, but clinicians should always follow institutional protocols and manufacturer guidelines for implantation.