đź“‹ FDA Reference
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 ?
510(k)
Number ?
K191551 ↗
Decision Date ?
December 23, 2019
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Provides percutaneous vascular access for neurovascular procedures through the radial artery.
- Facilitates the introduction of compatible catheters and instruments into the neurovascular system.
Clinical Applications
- Radial-artery access for diagnostic cerebral angiography.
- Radial-artery access for endovascular treatment of selected cerebral vascular conditions.
- Providing a stable conduit for compatible neurovascular catheters and devices during image-guided procedures.
Practical Considerations
- The sheath size should be selected to match the planned catheter or device and the patient's radial-artery diameter.
- Use requires clinicians trained in radial-artery access, neurovascular catheterization and management of access-site complications.
- Compatibility must be confirmed with the intended guidewires, catheters and therapeutic devices before use.
- Anticoagulation and radial-artery patency management should follow the treating team's neurointerventional protocol.
- MRI compatibility and conditions should be confirmed in the current manufacturer labeling; do not assume the sheath is safe during MRI.
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.