Deknatel Temporary Cardiac Pacing Wire
by Deknatel, Inc. 510(k)
Active
510(k) K873728
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873728 | Date3 Nov 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- LDF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Deknatel Temporary Cardiac Pacing Wire is an electrode, pacemaker, temporary device. It is a type of medical device used in cardiovascular applications.
The device is supplied with a product code of LDF and is regulated under regulation number 870.3680. It has been authorized by the FDA under the 510K clearance type and is classified as a class 2 device. The device is manufactured by Deknatel, Inc. and has a registration number of 1721676, among others.
Other devices from Deknatel, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Deknatel Temporary Cardiac Pacing Wire used for?
The Deknatel Temporary Cardiac Pacing Wire is used in cardiovascular applications as a temporary cardiac pacing electrode.
How is the Deknatel Temporary Cardiac Pacing Wire supplied?
The device is supplied with a product code of LDF and is regulated under regulation number 870.3680.
Is the Deknatel Temporary Cardiac Pacing Wire a single-use or reusable device?
The device description does not explicitly state whether it is single-use or reusable, but it is classified as a temporary device.
What is the regulatory status of the Deknatel Temporary Cardiac Pacing Wire?
The device has been authorized by the FDA under the 510K clearance type and is classified as a class 2 device.