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selectflex 072 neurovascular access system
Q'Apel
Summary: The SelectFlex 072 Neurovascular Access System is a medical device used to facilitate access in neurovascular procedures. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K181000 ↗
Decision Date
September 13, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The SelectFlex 072 Neurovascular Access System, manufactured by Q'Apel, received FDA clearance via the 510k pathway on September 13, 2018. It is classified as a Class 2 device under product code DQY.
What It Is
The SelectFlex 072 Neurovascular Access System is designed to provide a flexible and reliable means of accessing the neurovascular system. It consists of a catheter system that allows for precise navigation through the complex vascular pathways of the brain. This device is crucial for procedures requiring the placement of stents or other interventions within the neurovascular system.
Clinical Applications
This device is commonly used in procedures such as the placement of venous stents in the treatment of conditions like cerebral venous sinus thrombosis. It is typically utilized in hospital settings, particularly in interventional radiology and neurosurgery departments. The patient population includes those with neurovascular disorders requiring precise and minimally invasive intervention.
Indications for Use
The FDA indications for the SelectFlex 072 include facilitating access to the neurovascular system for the placement of devices like stents. It is intended for patients with conditions that necessitate intervention in the brain's vascular structures.
Practical Considerations
The SelectFlex 072 is compatible with a range of stents and other neurovascular devices. Clinicians should be aware of the catheter's sizing options to ensure compatibility with the patient's anatomy and the specific procedure. Proper technique in navigating the vascular system is essential to maximize the device's effectiveness.
Frequently Asked Questions
What is SelectFlex 072 Neurovascular Access System used for?
It is used to facilitate access to the neurovascular system for procedures such as stent placement.
What specialties typically use this device?
Interventional radiologists and neurosurgeons primarily use this device.
What are the FDA-cleared indications?
The device is indicated for facilitating access to the neurovascular system, particularly for the placement of stents and other interventions.
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.