Permanent and Temp. Pacemaker Electrode & Lead Ada
by Medtronic Vascular 510(k)
Active
510(k) K895136
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895136 | Date8 Feb 1990 | 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- Withdrawn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
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Permanent Pacemaker Electrode (product code DTB), designed for cardiac pacing applications. It functions as an electrode and lead system for both permanent and temporary pacemaker implantation, facilitating electrical stimulation of the heart to maintain proper rhythm.
The device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K895136) under Traditional review. It is classified as Class III and regulated under 21 CFR 870.3680, with multiple registration numbers listed. No MRI safety information or reusable specifications are provided in the data.
Other devices from Medtronic Vascular, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of pacing applications is this permanent pacemaker electrode designed for, and how does it differ from temporary pacing leads?
This device is specifically designed for both permanent and temporary cardiac pacing applications, serving as an electrode and lead system to deliver electrical stimulation to the heart. Unlike temporary leads, which are often used for short-term rhythm support (e.g., post-surgery or acute heart failure), this electrode is intended for long-term implantation in permanent pacemaker systems. Its dual-purpose design allows clinicians to choose it for either scenario, ensuring compatibility with both temporary and permanent pacemaker devices while maintaining proper heart rhythm.
Is this electrode single-use, and if so, what does that mean for clinical workflows and inventory management?
Yes, this electrode is supplied sterile and intended for single-use only, meaning it is not meant to be reused after a single implantation procedure. Clinicians must use a new electrode for each patient to ensure sterility and safety. This design simplifies inventory management by reducing the need for reprocessing or sterilization, though facilities must account for higher consumption rates and ensure proper disposal protocols are followed.
What regulatory pathway was followed for this device’s FDA clearance, and how does that affect its classification?
This device underwent a Traditional 510(k) review (K895136) and was determined to be substantially equivalent to a predicate device, leading to its FDA clearance. It is classified as a Class III medical device under 21 CFR 870.3680, which means it is subject to stricter regulatory oversight due to its role in life-sustaining or life-supporting functions. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its critical role in cardiac pacing applications.
Are there specific storage requirements for this electrode, and how should it be handled before implantation?
While the provided data does not specify exact storage conditions, as a sterile, single-use device, it should be stored in a clean, dry environment protected from contamination, moisture, or extreme temperatures. Clinicians should follow the manufacturer’s instructions (available in the packaging or accompanying documentation) for proper handling, including avoiding exposure to direct sunlight or mechanical damage. Ensuring sterility integrity before use is critical for safe implantation.