Model 5866-24 Pacemaker Lead Adaptor
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K864856 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 5866-24 Pacemaker Lead Adaptor is a Permanent Pacemaker Electrode, designed as a connector interface between pacemaker leads and implantable pulse generators. It facilitates electrical continuity and mechanical stability within cardiac pacing systems, ensuring reliable signal transmission for pacing therapy.
This device is intended for single-use in sterile cardiac electrophysiology procedures, adhering to Class III regulatory standards under FDA 510(k) clearance (K864856). Supplied sterile and packaged for surgical use, it must be handled in controlled environments such as operating rooms or electrophysiology labs. Compliance with 870.3680 and DTB product coding ensures traceability and adherence to cardiovascular device regulations.
Frequently asked questions
What is the primary purpose of the Model 5866-24 Pacemaker Lead Adaptor in a cardiac pacing system?
The Model 5866-24 Pacemaker Lead Adaptor serves as a connector interface between pacemaker leads and implantable pulse generators. Its role is to ensure reliable electrical continuity and mechanical stability, which are critical for maintaining consistent signal transmission during pacing therapy. This helps the pacemaker function effectively by bridging the lead and generator to deliver accurate pacing impulses to the heart.
Is the Model 5866-24 Pacemaker Lead Adaptor intended for reuse, or is it designed for single-use only?
The Model 5866-24 Pacemaker Lead Adaptor is explicitly designed for single-use in sterile cardiac electrophysiology procedures. It is supplied sterile and packaged for surgical use, meaning it should only be used once per patient to maintain sterility and safety standards. Reuse is not recommended or supported by the manufacturer.
Where should the Model 5866-24 Pacemaker Lead Adaptor be stored before use, and what are the handling requirements?
The Model 5866-24 Pacemaker Lead Adaptor must be stored in its original, sterile packaging until ready for use. It is intended for controlled environments like operating rooms or electrophysiology labs, where aseptic techniques are maintained. The packaging ensures sterility, so it should not be opened or handled outside of a sterile field until immediately before use.
How does the regulatory pathway for the Model 5866-24 Pacemaker Lead Adaptor differ from other cardiovascular devices?
The Model 5866-24 Pacemaker Lead Adaptor falls under Class III regulatory standards in the U.S., requiring a 510(k) clearance through the FDA. It was granted clearance under the Traditional 510(k) Review process by the Cardiovascular (CV) Advisory Committee, with a decision date of January 6, 1987. This classification reflects its role as a Permanent Pacemaker Electrode, which carries higher risk due to its direct involvement in life-sustaining cardiac pacing therapy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K864856 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K864856 24 fields · synced Sep 18, 2026