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selectflex 072 neurovascular access system
Q'Apel Medical
Summary: The SelectFlex 072 Neurovascular Access System is a medical device used for neurovascular access, primarily by interventional radiologists and neurosurgeons. It facilitates the delivery of therapeutic devices to the brain.
FDA Clearance Information
Pathway
510K
Number
K191664 ↗
Decision Date
August 30, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SelectFlex 072 was cleared through the FDA 510(k) pathway on August 30, 2019. Manufactured by Q'Apel Medical, it is a Class 2 device under product code DQY.
What It Is
The SelectFlex 072 Neurovascular Access System is designed to provide access to the neurovascular system, particularly for procedures involving the brain. It consists of a flexible catheter system that can navigate the complex vascular pathways of the brain. This device is crucial for delivering therapeutic agents or devices, such as stents, to treat conditions like aneurysms or other vascular abnormalities.
Clinical Applications
This device is commonly used in interventional radiology and neurosurgery settings, particularly for endovascular procedures. It is utilized in hospitals and specialized clinics where neurovascular interventions are performed. The patient population includes those with cerebrovascular conditions requiring precise and safe access to the brain's vasculature.
Indications for Use
The FDA-cleared indications for the SelectFlex 072 include providing access to the neurovascular system for the delivery of therapeutic devices. It is intended for patients with conditions such as aneurysms or other vascular abnormalities in the brain.
Practical Considerations
The SelectFlex 072 is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard neurovascular devices and requires careful handling to navigate the delicate brain vasculature. Clinicians should be trained in endovascular techniques for optimal use.
Frequently Asked Questions
What is SelectFlex 072 used for?
The SelectFlex 072 is used for accessing the neurovascular system to deliver therapeutic devices to the brain.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device for neurovascular procedures.
What are the FDA-cleared indications?
The device is indicated for providing access to the neurovascular system for delivering therapeutic devices to treat cerebrovascular conditions.
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.