Ventricular Pacing Leads Models 865/867
by Pacesetter Systems 510(k)
Active
510(k) K831435
Overview
The Ventricular Pacing Leads Models 865/867 are Permanent Pacemaker Electrodes, designed as flexible insulated electrical conductors. These leads connect an external pacemaker pulse generator to the heart’s ventricle, facilitating electrical stimulation to regulate cardiac rhythm in patients requiring ventricular pacing.
These leads are intended for single-use implantation in cardiac procedures and are classified under FDA regulation 870.3680. Supplied sterile and intended for use in clinical settings, they were granted FDA 510(k) clearance under the Traditional pathway in 1983. The models are categorized under product code DTB and fall under Class III regulatory classification, with no third-party manufacturing involvement.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831435 | Date8 Jun 1983 | 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- Withdrawn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 ventricular pacing leads designed for reuse in multiple patients, or are they intended for single-use only?
The Ventricular Pacing Leads Models 865/867 are explicitly designed for single-use implantation in cardiac procedures. The device description confirms they are supplied sterile and intended for clinical use in individual patients only, aligning with standard practices for permanent pacemaker electrodes to ensure patient safety and sterility.
What sizes or models are available for these ventricular pacing leads, and how do I identify them?
These leads come in two distinct models: 865 and 867. While the exact technical specifications (e.g., coil length, electrode type) aren’t detailed here, the model numbers differentiate their design for compatibility with specific pacemaker systems. Always verify the model against your pacemaker’s technical requirements or consult the manufacturer’s documentation to ensure proper pairing.
How should these leads be stored before use, and what precautions should be taken?
Since the leads are sterile and intended for single-use, they must be stored in their original, unopened packaging to maintain sterility. Store them in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for medical devices. Avoid contamination by keeping the packaging sealed until immediately before use in a sterile field.
What regulatory pathway was followed for FDA clearance of these leads, and what does that mean for their use?
The Ventricular Pacing Leads Models 865/867 were cleared via the FDA’s Traditional 510(k) pathway under the Cardiovascular (CV) Advisory Committee in 1983. This means the manufacturer demonstrated they are substantially equivalent to a legally marketed device already on the market, ensuring compliance with FDA standards for permanent pacemaker electrodes. Their classification as Class III reflects their critical role in cardiac function, though this does not imply ongoing third-party manufacturing oversight.