Permanent & Temp. Pacemaker Electrode
by Daig Corp. 510(k)
Active
510(k) K800795
Overview
This device is a Permanent and Temporary Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed to deliver electrical impulses to the heart, facilitating cardiac pacing for patients with bradycardia or conduction disorders. The electrode integrates with pacemaker systems to ensure proper heart rhythm regulation, available in both permanent and temporary configurations for acute or chronic use.
The electrode is supplied sterile and intended for single-use, though some models may be reusable under specific reprocessing protocols. It is regulated under FDA 510(k) clearance (K800795) and falls under the DTB product code, adhering to 870.3680 regulatory standards. Compatible with MRI environments when specified, it is available in multiple reference codes (e.g., 3002618605, 1028232) and must be stored according to manufacturer instructions to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800795 | Date30 Jun 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- Withdrawn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
- 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 patients is this pacemaker electrode designed to support, and how does it differ between permanent and temporary use?
This electrode is designed for patients with bradycardia or conduction disorders requiring cardiac pacing. The permanent configuration is intended for long-term implantation in patients needing chronic heart rhythm regulation, while the temporary version is for acute or short-term use, such as post-surgery or unstable cardiac conditions. Both integrate with pacemaker systems but differ in duration and clinical setting.
Is this device single-use, or can it be reused after reprocessing, and what does that entail?
The electrode is sterile and primarily intended for single-use to ensure patient safety and reliability. However, some models may allow reprocessing under specific protocols outlined by Daig Corp., provided they meet strict sterility and functionality standards. Reuse must strictly follow manufacturer guidelines to avoid compromising performance or infection risks.
How should this device be stored to maintain its integrity, and what are the implications of improper storage?
Storage must adhere to Daig Corp.’s manufacturer instructions to preserve sterility and functionality. Improper storage—such as exposure to moisture, extreme temperatures, or prolonged light—could compromise the electrode’s integrity, risking contamination or mechanical failure. Always check the packaging for expiration dates and storage conditions before use.
Are there different sizes or models available, and how do I identify the correct reference code for my application?
Multiple reference codes are available (e.g., 3002618605, 1028232, 3008988055), indicating variations in design or compatibility. The correct code depends on the specific pacemaker system and clinical need (permanent vs. temporary). Verify the code against your device’s documentation or consult Daig Corp. to ensure proper matching for safe and effective use.
Can this electrode be used in MRI environments, and what precautions should be taken if so?
Some models are compatible with MRI environments, but this depends on the specific electrode variant and manufacturer specifications. If MRI use is required, confirm compatibility with Daig Corp. and follow strict MRI safety protocols, including proper shielding and imaging parameters, to avoid interference or damage to the device.