Permanent Endocardial Unipolar Wedge Urethan Electrode
by Daig Corp. 510(k)
Active
510(k) K802553
Overview
This device is a permanent pacemaker electrode (OpenFDA classification: DTB) designed for endocardial implantation. It functions as a unipolar electrode, delivering precise electrical stimulation to cardiac tissue for pacing applications. The urethane-coated design facilitates stable fixation within the heart’s endocardium, ensuring reliable signal transmission for chronic use.
The electrode is intended for single-use implantation during cardiac procedures and is classified as a Class III medical device under FDA regulations (21 CFR 870.3680). It requires sterile handling and is supplied pre-sterilized for direct surgical use. No additional regulatory approvals beyond the FDA 510(k) clearance (K802553) are referenced in the data. Compliance with traditional 510(k) review by the Cardiovascular (CV) Advisory Committee is noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802553 | Date16 Jan 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- Withdrawn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
- Full name
- Perm. Endocardial Unipolar Wedge Urethan
- 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 Daig Corp.
Questions
What is the primary purpose of the urethane-coated design on this endocardial electrode, and how does it benefit the patient during long-term use?
The urethane coating on this permanent endocardial unipolar electrode is designed to enhance stable fixation within the heart’s endocardium. This ensures reliable signal transmission for chronic pacing applications, reducing the risk of displacement or loosening over time, which is critical for long-term reliability in patients requiring consistent cardiac stimulation.
Is this device intended for reuse, or is it meant to be implanted once and left in place permanently? How does this affect its sterility requirements?
This device is explicitly designed for single-use implantation during cardiac procedures, meaning it is not intended for reuse. Because it is implanted permanently, it must be handled in a sterile manner—it is supplied pre-sterilized for direct surgical use to ensure infection control and patient safety during the procedure.
What regulatory pathway was followed for this device’s approval, and which advisory committee was involved in the review process?
This device underwent a traditional 510(k) review by the FDA, classified as substantially equivalent under the Cardiovascular (CV) Advisory Committee. The clearance (K802553) was granted in 1981, confirming compliance with FDA regulations for permanent pacemaker electrodes (21 CFR 870.3680).
How is this electrode supplied, and what precautions should be taken during handling to maintain its integrity?
The electrode is supplied pre-sterilized in a sterile packaging for direct surgical use, ensuring no additional preparation is required before implantation. Since it is intended for single-use, it must be handled with sterile techniques to prevent contamination, and any unused portions should be discarded to avoid cross-infection risks.