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rist cath radial access long sheath
Rist Neurovascular
Summary: The Rist Cath Radial Access Long Sheath is a medical device used for radial artery access in neurovascular procedures. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway 510K
Number K191551 ↗
Decision Date December 23, 2019
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Rist Cath Radial Access Long Sheath was cleared through the FDA 510k pathway on December 23, 2019. It is manufactured by Rist Neurovascular and is classified as a Class 2 device.
What It Is
The Rist Cath Radial Access Long Sheath is a specialized catheter designed to facilitate access to the neurovascular system via the radial artery. It provides a long, flexible conduit that allows for the passage of diagnostic and therapeutic tools to the target site within the cerebral vasculature. This device is particularly useful in procedures requiring precise navigation and stability within the complex anatomy of the brain's blood vessels.
Clinical Applications
This device is commonly used in neurointerventional procedures such as angiography, stenting, and embolization. It is particularly beneficial in settings where radial artery access is preferred over femoral access, such as in patients with peripheral vascular disease or those who require a quicker recovery time. The device is typically used by specialists in interventional radiology and neurosurgery, often in hospital or specialized clinic settings.
Indications for Use
The FDA-cleared indications for this device include its use in procedures that require vascular access to the brain via the radial artery. It is suitable for patients who need neurovascular interventions, such as those with cerebral aneurysms or arteriovenous malformations.
Practical Considerations
Clinicians should consider the appropriate sizing of the sheath to match the patient's radial artery diameter. The device is compatible with a range of neurovascular tools, and its use requires proficiency in radial access techniques. It is important to ensure proper anticoagulation during procedures to prevent thrombosis.
Frequently Asked Questions
What is Rist Cath Radial Access Long Sheath used for?
It is used for accessing the neurovascular system via the radial artery in procedures like angiography and stenting.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in neurovascular procedures requiring radial artery access, such as treating cerebral aneurysms.
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.