Electrode, Pacemaker, Permanent
by Pacesetter Systems 510(k)
Active
510(k) K810139
Overview
This device is a Permanent Pacemaker Electrode, classified under FDA nomenclature as a Class III medical device. It is designed for implantation within the cardiovascular system to stimulate the heart muscle, ensuring proper heart rhythm and addressing arrhythmias by delivering electrical impulses to the heart chambers.
The Electrode, Pacemaker, Permanent is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K810139) and falls under the DTB product code, adhering to regulatory standards for cardiovascular devices. Multiple model references are associated with this device, ensuring compatibility with various pacemaker systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810139 | Date27 Nov 1981 | 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- Withdrawn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 permanent pacemaker electrode, and how is it used in clinical practice?
This permanent pacemaker electrode is designed to be surgically implanted within the cardiovascular system to deliver electrical impulses to the heart chambers. Its purpose is to stimulate the heart muscle and maintain proper heart rhythm, helping to manage arrhythmias by ensuring consistent and effective pacing.
Is this device intended for single-use or can it be reused after implantation?
The device is supplied sterile and explicitly intended for single-use only. Once implanted, it should not be removed or reused, as this could compromise patient safety and device efficacy.
How many model references are associated with this pacemaker electrode, and why does this matter?
Multiple model references (listed in the specifications) are associated with this device to ensure compatibility with various pacemaker systems. This flexibility allows clinicians to select the appropriate electrode for different patient needs and device configurations, improving clinical versatility.
What regulatory pathway was followed for FDA clearance of this permanent pacemaker electrode?
This device underwent a traditional 510(k) clearance process through the FDA, classified as a Class III medical device. The clearance was granted under the decision code 'SESE' (Substantially Equivalent) and falls under the DTB product code, adhering to cardiovascular device regulations.
How should this electrode be stored before use, and what precautions should be taken?
Since the electrode is supplied sterile for single-use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. The packaging must remain intact until immediate use to maintain sterility and prevent contamination.