Pacemaker, Electrode, Permanent & Temp.
by Daig Corp. 510(k)
Active
510(k) K780246
Overview
This device is a Permanent Pacemaker Electrode, classified under product code DTB, designed for use in cardiac pacing systems. It provides electrical stimulation to regulate heart rhythm in patients with bradycardia or other conduction disorders, serving as both a permanent and temporary solution depending on clinical need.
The electrode is intended for sterile implantation in cardiac surgery or electrophysiology procedures, supplied as a reusable component within a pacemaker system. It adheres to FDA 510(k) clearance (K780246) under Traditional review, with regulatory compliance under 21 CFR 870.3680. Multiple model references are listed, ensuring compatibility with various pacemaker systems, though specific sizing and sterility instructions must follow manufacturer guidelines.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780246 | Date31 Aug 1978 | 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- Withdrawn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 Daig Corp.
Questions
What types of heart conditions is this electrode designed to address, and how does it function within a pacemaker system?
This electrode is designed for patients with bradycardia or conduction disorders, providing electrical stimulation to regulate heart rhythm. It serves as part of a permanent or temporary cardiac pacing system, delivering timed impulses to the heart to maintain a consistent and effective heartbeat when the natural conduction system is impaired.
Is this electrode intended for single-use or reusable applications, and what are the sterility requirements?
The electrode is supplied as a reusable component within a pacemaker system, intended for sterile implantation during cardiac surgery or electrophysiology procedures. Sterility must be maintained according to manufacturer guidelines, as it is implanted directly into the body.
How do I determine which model of this electrode is compatible with my existing pacemaker system?
This device comes in multiple model references, each designed for compatibility with various pacemaker systems. The manufacturer provides specific sizing and compatibility details, so you should consult their documentation or technical support to ensure the correct model is selected for your patient’s pacemaker system.
What regulatory pathway was followed for this device’s approval, and which advisory committee was involved?
This electrode received FDA clearance through a 510(k) submission under Traditional review, classified under product code DTB and regulated under 21 CFR 870.3680. The Cardiovascular (CV) Advisory Committee was involved in the review process, as indicated by the submission details.
Are there specific storage instructions for this electrode, and how should it be handled before implantation?
While the provided data does not specify exact storage conditions, electrodes intended for sterile implantation typically require protection from contamination and moisture. The manufacturer’s guidelines should be followed to ensure proper handling, storage, and preparation before use in cardiac surgery or electrophysiology procedures.