Lead, Tined Pacing, Implantable (K800354)
by Daig Corp. 510(k)
Active
510(k) K800354
Overview
This device is a permanent pacemaker electrode, classified under product code DTB, designed for cardiac pacing applications. It employs tined leads to anchor within the heart, ensuring stable electrical stimulation for patients with arrhythmias or conduction disorders.
The lead is intended for implantable use in cardiac procedures and is supplied as a reusable medical device. It has received FDA 510(k) clearance under the Traditional review pathway, with a decision date of May 30, 1980. No additional sterility, MRI safety, or size specifications are provided in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800354 | Date30 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- Withdrawn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
- Lead, Tined Pacing, Implantable
- 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 tined pacing lead, and how does it differ from other pacing leads?
This tined pacing lead from Daig Corp. is designed specifically for permanent cardiac pacing to treat arrhythmias or conduction disorders. The 'tined' feature refers to its anchoring mechanism, which allows it to secure itself within the heart tissue for stable electrical stimulation—unlike non-tined leads, which rely on passive fixation. It is classified under product code DTB and is intended for implantable use in cardiac procedures.
Is this lead single-use or reusable, and what does that mean for clinical workflow?
This lead is explicitly labeled as a reusable medical device, meaning it is intended for multiple uses after proper cleaning, sterilization, and maintenance. Clinically, this allows for cost efficiency and reduces waste, though facilities must adhere to strict reprocessing protocols to ensure patient safety and device integrity between uses.
What regulatory pathway was followed for FDA clearance, and what does that imply about its safety and equivalence?
The lead received FDA 510(k) clearance under the Traditional review pathway, with a decision date of May 30, 1980. This classification means it was determined to be substantially equivalent (SESE) to a legally marketed device already on the market, implying it meets the same safety and performance standards as its predicate. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee.
Are there any specific storage or handling instructions mentioned for this device?
The provided regulatory data does not include explicit sterility, storage, or handling instructions for this reusable lead. Clinicians should follow manufacturer guidelines (e.g., Daig Corp.’s instructions) for proper storage, cleaning, and reprocessing to maintain functionality and prevent contamination. Since it is reusable, adherence to reprocessing protocols is critical to ensure patient safety.