Unipolar Atrial J Pacing Lead Model 869
by Pacesetter Systems 510(k)
Active
510(k) K831436
Overview
The Unipolar Atrial J Pacing Lead Model 869 is a Permanent Pacemaker Electrode, designed for atrial pacing in cardiac rhythm management. It delivers electrical stimulation to the right atrium via a unipolar configuration, facilitating consistent pacing support for patients with bradycardia or conduction disorders.
This device is supplied sterile and intended for single-use implantation within a cardiac surgery or electrophysiology setting. It adheres to FDA 510(k) clearance (K831436) under regulation 870.3680, classified as a Class III device. The lead is compatible with MRI environments as per its designated product code (DTB) and regulatory filings, though specific MRI safety parameters should be confirmed with the manufacturer’s guidelines.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831436 | 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- Withdrawn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
What is the primary purpose of the Unipolar Atrial J Pacing Lead Model 869, and how does it function in a patient’s heart?
The Unipolar Atrial J Pacing Lead Model 869 is designed specifically for atrial pacing in cardiac rhythm management. It delivers electrical stimulation to the right atrium using a unipolar configuration, providing consistent pacing support for patients with bradycardia or conduction disorders. This ensures reliable atrial contraction, helping maintain proper heart rhythm.
Is this device intended for single-use or reusable implantation, and what are the sterility and handling requirements?
This lead is sterile upon supply and explicitly intended for single-use implantation only. It must be used in a cardiac surgery or electrophysiology setting and should not be reused after implantation to prevent infection or performance degradation. Proper sterile handling and aseptic techniques are required before use.
What are the key specifications regarding MRI compatibility for this pacing lead?
The Unipolar Atrial J Pacing Lead Model 869 is compatible with MRI environments, as indicated by its product code (DTB) and regulatory filings. However, specific MRI safety parameters (e.g., field strength, imaging sequences) should always be verified with the manufacturer’s guidelines before use to ensure patient safety and device performance.
How is this device classified under FDA regulations, and what does that mean for its use?
This lead is classified as a Class III medical device under FDA regulation 870.3680, meaning it requires premarket approval or a 510(k) clearance due to its role in life-sustaining or life-supporting functions. Its FDA 510(k) clearance (K831436) confirms it is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for atrial pacing applications.