Identifiers
- 510(k) Number
- K790988 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 6971 Deep Brain Stimulation Wire is a Permanent Pacemaker Electrode, designed for use in deep brain stimulation (DBS) systems. This device facilitates electrical stimulation of specific brain regions to manage neurological disorders, such as Parkinson’s disease, essential tremor, or dystonia, by delivering precise, programmable impulses via implanted electrodes.
This wire is supplied sterile and intended for single-use implantation within the brain’s target regions. It is classified as a Class III medical device under FDA regulations and requires FDA 510(k) clearance for commercial distribution. The device is non-magnetic and must be handled with sterile techniques in an operating room or interventional suite, adhering to strict aseptic protocols. Authorized for use in cardiovascular and neurological settings, it is regulated under 21 CFR 870.3680 and associated registration numbers.
Frequently asked questions
What neurological conditions is the Model 6971 DBS Wire approved to help manage through deep brain stimulation?
The Model 6971 DBS Wire is designed for use in deep brain stimulation systems to manage neurological disorders such as Parkinson’s disease, essential tremor, and dystonia. It delivers programmable electrical impulses to specific brain regions to help control symptoms associated with these conditions.
Is the Model 6971 DBS Wire intended for reuse, or is it meant to be implanted as a single-use device?
The Model 6971 DBS Wire is supplied sterile and explicitly intended for single-use implantation within the brain. It must be handled under strict aseptic protocols in an operating room or interventional suite, ensuring no reuse occurs.
How should the Model 6971 DBS Wire be stored before use, and what precautions should be taken?
While the storage instructions are not explicitly detailed in the provided data, the device is sterile and must be handled with sterile techniques. It should be stored in its original packaging, protected from contamination, and used only in a controlled environment like an operating room or interventional suite to maintain sterility and integrity.
What regulatory pathway was followed for the Model 6971 DBS Wire’s FDA clearance, and what classification does it hold?
The Model 6971 DBS Wire is classified as a Class III medical device under FDA regulations and required a 510(k) clearance for commercial distribution. The clearance was granted through a traditional review pathway by the Cardiovascular (CV) Advisory Committee, with a decision of *Substantially Equivalent* (SESE).
Can the Model 6971 DBS Wire be used in both cardiovascular and neurological settings, or is it limited to one specialty?
While the device is authorized for use in cardiovascular and neurological settings based on its regulatory filing, its primary intended use is for deep brain stimulation in neurological applications. The cardiovascular reference in the data pertains to the advisory committee classification (CV) during the 510(k) review process, not its clinical application.
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 | K790988 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K790988 24 fields · synced Oct 6, 2026