Permanent Pacemaker Electrode
by Daig Corp. 510(k)
Active
510(k) K830464
Overview
This device is a permanent pacemaker electrode, classified as a Class III medical device under FDA regulations. It is designed for implantation within the cardiovascular system to deliver electrical impulses to the heart, regulating its rhythm for patients with bradycardia or other conduction disorders. The electrode provides both permanent and temporary pacing capabilities, ensuring reliable cardiac support.
The electrode is intended for surgical implantation by qualified healthcare professionals in a sterile operating environment. It is supplied as a reusable component, compatible with various pacemaker systems, and must be handled according to strict aseptic techniques. Regulated under FDA 510(k) clearance (K830464), it adheres to the Permanent Pacemaker Electrode nomenclature (DTB product code, regulation 870.3680) and is distributed by Daig Corp. for cardiovascular applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830464 | Date16 Mar 1983 | 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- Withdrawn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
- Pacemaker Electrode Perm. & Temp
- 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 work?
This electrode is designed for patients with bradycardia or conduction disorders, providing both permanent and temporary pacing capabilities. It delivers electrical impulses to regulate the heart’s rhythm by stimulating the cardiac muscle, ensuring consistent contractions and maintaining proper heart function.
Is this electrode reusable, and if so, what precautions must be taken during handling?
Yes, this electrode is supplied as a reusable component. Due to its surgical implantation within the cardiovascular system, it must be handled under strict aseptic techniques in a sterile operating environment to prevent infection or contamination.
What regulatory pathway was followed for this device’s approval, and which advisory committee reviewed it?
This device followed the FDA’s 510(k) clearance pathway, specifically a traditional review process, and was deemed substantially equivalent to a predicate device. The Cardiovascular (CV) Advisory Committee reviewed the submission as part of the regulatory process.
Are there multiple sizes or models available for this electrode, and how would a clinician determine the correct fit?
The data provided lists multiple FEI (Final Establishment Identification) numbers, which may correspond to different lot or batch identifiers, but no specific size or model variations are detailed. A clinician would rely on patient-specific anatomical and clinical factors, along with manufacturer guidelines, to select the appropriate electrode for implantation.