Pacing Electrode
by Pacesetter Systems 510(k)
Active
510(k) K834431
Overview
The Pacing Electrode is a Permanent Pacemaker Electrode, classified under FDA regulation 870.3680. This device is designed to deliver electrical stimulation to the heart muscle, facilitating cardiac pacing in patients with conduction abnormalities or arrhythmias. It serves as a critical component of a pacemaker system, ensuring proper heart rhythm regulation through direct myocardial stimulation.
Pacing Electrodes are implanted via surgical procedures, typically positioned in the right atrium, right ventricle, or coronary sinus. They are supplied sterile and intended for single-use implantation, though some models may be reusable under specific conditions. The device adheres to FDA 510(k) clearance (K834431) and falls under the DTB product code, with regulatory classification as a Class III medical device. Storage and handling must comply with sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834431 | Date12 Mar 1984 | 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- Withdrawn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 this pacing electrode, and where is it typically implanted in the body?
This pacing electrode is designed to deliver electrical stimulation directly to the heart muscle, helping regulate abnormal heart rhythms or conduction issues in patients. It is typically implanted surgically in the right atrium, right ventricle, or coronary sinus, depending on the patient’s clinical needs and the specific model used.
Is this device intended for single-use or can it be reused after implantation?
The device is primarily supplied sterile and intended for single-use implantation. However, some models may be reusable under specific conditions, though this would depend on manufacturer guidelines and clinical protocols to ensure sterility and safety.
How should this pacing electrode be stored, and what precautions should be taken during handling?
Since this is a sterile medical device, storage and handling must follow strict sterile medical device protocols. It should be kept in its original packaging until ready for use, protected from contamination, and stored in a clean, dry environment to maintain sterility.
What regulatory pathway was followed for this device’s approval, and which committee reviewed it?
This pacing electrode was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type. It was reviewed by the Cardiovascular (CV) Advisory Committee and classified as a Class III medical device, indicating higher regulatory oversight due to its critical role in cardiac pacing.