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model 6971 w dbs wire
Medtronic Vascular
Summary: The Model 6971 with DBS Wire is a medical device used in the management of certain vascular conditions. It is primarily utilized by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K790988 ↗
Decision Date
June 11, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on June 11, 1979, by Medtronic Vascular. It is classified as a Class III device under product code DTB.
What It Is
The Model 6971 with DBS Wire is a deep brain stimulation (DBS) wire used in conjunction with implantable devices to manage neurological conditions. It is designed to deliver electrical impulses to specific areas of the brain, helping to modulate neural activity. This device is crucial in the treatment of movement disorders such as Parkinson's disease.
Clinical Applications
Clinically, the Model 6971 with DBS Wire is used in neurosurgical procedures to manage conditions like Parkinson's disease, dystonia, and essential tremor. It is typically used in specialized centers by neurosurgeons and neurologists. The device is implanted in patients who have not responded adequately to medication, providing an alternative therapeutic option.
Indications for Use
The FDA indications suggest that this device is intended for patients with movement disorders that are not adequately controlled with medication. It is specifically designed for use in deep brain stimulation procedures.
Practical Considerations
When using the Model 6971 with DBS Wire, clinicians should consider the compatibility with existing implantable pulse generators. Proper placement and programming are crucial for optimal outcomes. The device requires careful handling during implantation to avoid damage.
Frequently Asked Questions
What is Model 6971 w DBS Wire used for?
It is used for deep brain stimulation in the treatment of movement disorders such as Parkinson's disease.
What specialties typically use this device?
Neurosurgeons and neurologists specializing in movement disorders typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with movement disorders that are not adequately controlled with medication, specifically for deep brain stimulation procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.