Permanent Pacemaker Electrode
by Daig Corp. 510(k)
Active
510(k) K800352
Overview
This device is a Permanent Pacemaker Electrode, classified under the nomenclature for cardiovascular implants. It is designed to be implanted within the heart to deliver electrical impulses, regulating heart rhythm in patients with bradycardia or other conduction disorders. The electrode interfaces with a pacemaker system to ensure proper pacing and synchronization of cardiac contractions.
The Permanent Pacemaker Electrode is intended for surgical implantation by qualified medical professionals in a clinical setting. It is supplied sterile and intended for single-use, though specific models may vary in design and lead configuration. Compliance with FDA_510K clearance under device_class=3 and regulation_number=870.3680 ensures adherence to cardiovascular device standards. Storage and handling must follow manufacturer guidelines to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800352 | Date28 May 1980 | 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- Withdrawn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
- 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 this pacemaker electrode, and how does it work with a pacemaker system?
This pacemaker electrode is designed to be surgically implanted inside the heart to deliver controlled electrical impulses. It works in conjunction with an external pacemaker system to regulate heart rhythm, particularly in patients with bradycardia or conduction disorders. The electrode ensures proper pacing and synchronization of cardiac contractions by interfacing with the pacemaker, maintaining consistent electrical stimulation where the heart’s natural rhythm is insufficient.
Is this device intended for single-use only, or can it be reused after implantation?
The device is explicitly supplied sterile and intended for single-use according to the manufacturer’s guidelines. While some components of pacemaker systems may be reusable, this electrode is not designed for reuse to ensure patient safety and sterility. Always follow the manufacturer’s instructions for proper handling and disposal.
What storage and handling precautions should be taken to maintain the electrode’s sterility and functionality?
To preserve sterility and functionality, the electrode must be stored and handled according to the manufacturer’s (Daig Corp.) specific guidelines. This typically includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination or physical damage, as these could compromise its performance before implantation.
What regulatory pathway was followed for this device’s approval, and which advisory committee was involved?
This pacemaker electrode was cleared through the FDA’s 510(k) pathway, specifically under Traditional Review with a decision code of SESE (Substantially Equivalent). The Cardiovascular (CV) Advisory Committee was involved in the review process, ensuring compliance with 21 CFR 870.3680 for cardiovascular devices. The clearance confirms it meets FDA standards for safety and effectiveness as a permanent pacemaker electrode.