Permanent & Temp. Pacemaker Electrode
by Daig Corp. 510(k)
Active
510(k) K802547
Overview
This device is a Permanent and Temporary Pacemaker Electrode, classified as a Class III medical device under FDA regulation 870.3680. It is designed to deliver electrical impulses to the heart, facilitating cardiac pacing for both permanent and temporary indications. The electrode interfaces with pacemaker systems to regulate heart rhythm in patients with bradycardia or conduction disorders.
The device is supplied sterile for single-use or reusable applications, depending on model specifications. It is intended for use in clinical settings such as hospitals and cardiac care units, where temporary pacing may be required during acute cardiac events or pre-permanent pacemaker implantation. Authorized under FDA 510(k) clearance (K802547), it adheres to regulatory standards for cardiovascular devices, ensuring compatibility with MRI-safe environments where applicable. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK802547 | 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- Withdrawn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
- 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 pacemaker electrode designed to address, and how does it work in those cases?
This electrode is designed to address bradycardia (slow heart rate) and conduction disorders by delivering electrical impulses to regulate heart rhythm. It interfaces with pacemaker systems to ensure consistent contractions, which is critical for patients experiencing slow or irregular heartbeats. The device is suitable for both permanent and temporary pacing needs, such as during acute cardiac events or pre-permanent pacemaker implantation.
Is this electrode available in single-use or reusable options, and how should it be stored to maintain sterility?
The electrode is supplied sterile for either single-use or reusable applications, depending on the specific model. To maintain sterility and functionality, storage and handling must follow Daig Corp.’s manufacturer guidelines, which likely include keeping it in a sealed, dry environment away from direct sunlight or extreme temperatures.
What types of clinical settings is this device intended for, and does it have compatibility with MRI environments?
This device is intended for use in clinical settings like hospitals and cardiac care units, where temporary or permanent pacing may be required. Some models are designed to be compatible with MRI-safe environments, though compatibility specifics should be verified with Daig Corp. or the device’s labeling, as MRI safety depends on the electrode’s construction and the imaging protocol used.
How do I determine which model or size of this electrode is appropriate for my patient?
The appropriate model or size depends on the patient’s clinical needs, such as whether temporary or permanent pacing is required, as well as anatomical factors like vein accessibility and pacing site. Daig Corp. provides multiple electrode options, and selecting the correct one typically involves consulting the device’s specifications, manufacturer recommendations, or working with a cardiologist or electrophysiologist to ensure proper fit and function.