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Mivi Neurovascular
Summary: The q3-q6 distal access catheters by Mivi Neurovascular are used in neurovascular procedures to provide distal access within the vasculature. They are typically utilized by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway 510K
Number K192558 ↗
Decision Date April 6, 2020
Product Code DQY
Device Class Class 2
Evidence 0 studies
The q3-q6 distal access catheters were cleared through the FDA 510(k) pathway on April 6, 2020. Manufactured by Mivi Neurovascular, these devices are classified as Class 2 under product code DQY.
What It Is
The q3-q6 distal access catheters are medical devices designed to facilitate access to distal regions of the neurovascular system. These catheters are flexible, allowing navigation through the complex vascular pathways of the brain. They are used to deliver therapeutic agents or to assist in the placement of other devices such as stents.
Clinical Applications
These catheters are commonly used in neurointerventional procedures, such as thrombectomy for acute ischemic stroke, where rapid access to cerebral arteries is crucial. They are also used in the treatment of cerebral aneurysms and arteriovenous malformations. The devices are typically employed in hospital settings by specialists in interventional neuroradiology and endovascular neurosurgery.
Indications for Use
The FDA-cleared indications for these catheters include providing distal access in the neurovascular system, which is essential for procedures like thrombectomy or the deployment of stents in patients with vascular conditions affecting the brain.
Practical Considerations
The q3-q6 catheters come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with standard guidewires and other neurointerventional devices. Clinicians should be familiar with catheter navigation techniques to minimize the risk of vascular injury.
Frequently Asked Questions
What is q3-q6 distal access catheter used for?
These catheters are used to access distal regions of the neurovascular system for procedures like thrombectomy and stent placement.
What specialties typically use this device?
Interventional radiologists and neurosurgeons specializing in neurovascular procedures commonly use these catheters.
What are the FDA-cleared indications?
These catheters are indicated for providing distal access in the neurovascular system, facilitating procedures such as thrombectomy and stent deployment.
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.