Permanent Pacemaker Electrode
by Daig Corp. 510(k)
Active
510(k) K800351
Overview
This device is a permanent and temporary pacemaker electrode, classified under the nomenclature for cardiac pacing systems. It is designed to deliver electrical impulses to the heart muscle to regulate heart rhythm, serving both permanent and temporary pacing applications in patients with bradycardia or conduction disorders.
The electrode is supplied as a reusable medical device, intended for use in clinical settings such as hospitals and cardiac care units. It is regulated under FDA 510(k) clearance (K800351) and falls under the Cardiovascular advisory committee classification, adhering to Device Type DTB and Regulation 870.3680. Sterility and compatibility with MRI environments are not specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800351 | 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- Withdrawn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, 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 clinical settings is this pacemaker electrode intended for, and how is it supplied?
This device is designed for use in clinical settings such as hospitals and cardiac care units. It is supplied as a reusable medical device, meaning it is meant to be cleaned, disinfected, and reused for multiple patients under controlled conditions in a healthcare facility.
What regulatory pathway was followed for this device’s FDA clearance, and which advisory committee was involved?
This pacemaker electrode received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional 510(k) review pathway. The device was classified under the Cardiovascular advisory committee (CV) and falls under Device Type DTB, regulated by FDA regulation 870.3680. The clearance was granted in 1980, with the decision described as *Substantially Equivalent* to a predicate device.
Does this device come in multiple sizes or models, and if so, how can I identify them?
Yes, this pacemaker electrode is available in multiple models, as indicated by the OpenFDA registration numbers (e.g., 3002618605, 1028232, etc.). These identifiers correspond to different variants or batches of the device, but the data does not specify exact size differences or clinical distinctions between them. For precise sizing or model-specific details, refer to Daig Corp.’s official documentation or catalog.
Is this device compatible with MRI environments, and what storage or handling considerations should be noted?
The provided data does not specify whether this pacemaker electrode is MRI-compatible. As a reusable device, it should be stored in a clean, dry environment per manufacturer guidelines to prevent contamination. Proper sterilization or disinfection protocols must be followed before reuse, as outlined in Daig Corp.’s instructions for use.