Unipolar Lead Configuration Conductor
by Daig Corp. 510(k)
Active
510(k) K770468
Overview
The Unipolar Lead Configuration Conductor is a Permanent Pacemaker Electrode (product code DTB), designed to facilitate electrical conduction between a cardiac pacemaker and heart tissue. As a unipolar lead, it employs a single conductor to deliver pacing stimuli, enabling synchronized cardiac rhythm management in patients requiring long-term pacing support.
This device is intended for use in cardiac pacing systems and is supplied as a reusable component, adhering to regulatory standards under FDA 510(k) clearance (K770468). It falls under Class III regulatory classification, requiring premarket approval for certain variants, and is manufactured by Daig Corp. (Mchenry, IL). No specific sterility or MRI safety details are provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770468 | Date5 Apr 1977 | 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- Withdrawn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 is the primary purpose of the Unipolar Lead Configuration Conductor from Daig Corp. and how does it differ from other pacing leads?
The Unipolar Lead Configuration Conductor is designed specifically for use in cardiac pacing systems to deliver pacing stimuli to heart tissue using a single conductor. Unlike bipolar leads, which use two conductors, this unipolar design simplifies the electrical pathway, enabling synchronized cardiac rhythm management in patients requiring long-term pacing support. It is classified as a Permanent Pacemaker Electrode (product code DTB) and is intended for integration with pacemaker devices.
Is the Unipolar Lead Configuration Conductor reusable, and what does this mean for clinical workflows?
Yes, the Unipolar Lead Configuration Conductor is supplied as a reusable component. This means it is intended to be used multiple times after appropriate cleaning, sterilization, and maintenance procedures, which can streamline clinical workflows by reducing the need for single-use replacements. However, reuse must comply with regulatory standards and manufacturer guidelines to ensure safety and efficacy.
What regulatory pathway was followed for the FDA clearance of this device, and what does this imply for its use?
The Unipolar Lead Configuration Conductor received FDA clearance through a 510(k) premarket submission (K770468), filed in 1977, and was determined to be *substantially equivalent* to a legally marketed predicate device. This clearance was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee under a traditional 510(k) process. The classification as a Class III device for certain variants implies that while this specific model was cleared via 510(k), other variants may require Premarket Approval (PMA). Clinicians should confirm the specific model’s regulatory status before use.
Are there any specific storage requirements or considerations for the Unipolar Lead Configuration Conductor?
The provided data does not specify storage requirements such as temperature, humidity, or shelf life for the Unipolar Lead Configuration Conductor. However, as a reusable medical device, it should be stored in a clean, dry environment to prevent contamination and degradation. Clinicians should follow Daig Corp.’s instructions for maintenance and storage to ensure proper functionality and longevity.