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Mivi Neuroscience
Summary: The Mivi mi-ext Extension Catheter is a medical device used primarily in neurovascular procedures to facilitate access and support during interventions. It is typically used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K163233 ↗
Decision Date
April 6, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Mivi mi-ext Extension Catheter was cleared through the FDA 510k pathway on April 6, 2017. Manufactured by Mivi Neuroscience, it is a Class 2 device under product code DQY.
What It Is
The Mivi mi-ext Extension Catheter is a flexible tube designed to be inserted into the vascular system to extend the reach of other catheters during neurovascular procedures. It provides support and stability, allowing clinicians to navigate complex vascular pathways with precision. The device comes in various sizes to accommodate different anatomical and procedural needs.
Clinical Applications
This device is commonly used in interventional neuroradiology and endovascular neurosurgery. It is particularly useful in procedures requiring access to the cerebral vasculature, such as thrombectomy for acute ischemic stroke or the placement of stents in venous stenosis. The catheter's design allows it to be used in both hospital and outpatient settings, catering to adult and pediatric populations.
Indications for Use
The Mivi mi-ext Extension Catheter is indicated for use in procedures requiring vascular access and support, particularly in the neurovascular system. It is suitable for patients undergoing interventions for conditions like stroke or venous stenosis.
Practical Considerations
Clinicians should select the catheter size based on the patient's anatomy and the specific procedural requirements. Compatibility with other devices, such as guidewires and stents, should be confirmed prior to use. Proper technique in catheter navigation and placement is crucial to avoid complications.
Frequently Asked Questions
What is the Mivi mi-ext Extension Catheter used for?
It is used to facilitate access and support during neurovascular procedures, such as thrombectomy or stent placement.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in vascular access and support during neurovascular interventions, such as those for stroke or venous stenosis.
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.