Endocardial Electrode
by Vitatron Medical BV 510(k)
Active
510(k) K810928
Overview
The Endocardial Electrode is a Permanent Pacemaker Electrode, designed for implantation within the heart to facilitate cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders, ensuring proper synchronization of cardiac contractions.
This device is supplied sterile and intended for single-use implantation during cardiac procedures. It is classified as a Class III medical device under FDA regulations (870.3680) and requires FDA 510(k) clearance. The electrode is compatible with MRI environments under specific conditions, as outlined in its technical documentation, and must be handled using aseptic techniques prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810928 | Date2 Jul 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- Withdrawn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 Vitatron Medical BV
Questions
Is this electrode designed for repeated use or is it intended for single-use only during implantation?
The Endocardial Electrode from Vitatron Medical BV is explicitly designed for single-use implantation only. It is supplied sterile and must be used once during a cardiac procedure, after which it is not intended to be reused. This aligns with standard practices for permanent pacemaker electrodes to ensure patient safety and sterility.
What types of heart conditions is this electrode intended to address, and how does it work?
This electrode is intended for patients with bradycardia or conduction disorders, delivering electrical impulses to regulate heart rhythm. It works by facilitating cardiac pacing—synchronizing contractions of the heart chambers to maintain proper heart function. It is implanted within the heart to ensure consistent pacing support.
Can this device be used in patients who require MRI scans, and if so, are there specific conditions or precautions?
The Endocardial Electrode is compatible with MRI environments under specific conditions, as detailed in its technical documentation. However, MRI use must follow strict guidelines to avoid risks like heating or displacement. Always consult the manufacturer’s instructions or a radiologist to confirm compatibility and safety protocols before MRI procedures.
How should the electrode be stored before use, and what precautions should be taken?
Since the electrode is supplied sterile, it must be stored in its original packaging until ready for use to maintain sterility. Handling should follow aseptic techniques—avoiding contamination, extreme temperatures, or physical damage. Check the packaging for expiration dates and storage instructions to ensure optimal performance and safety.