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axs infinity ls plus long sheath
Stryker Neurovascular
Summary: The axs infinity ls plus long sheath is a medical device used in neurovascular procedures, primarily by interventional radiologists and neurosurgeons. It facilitates access to the venous system for stent placement.
FDA Clearance Information
Pathway
510K
Number
K193034 ↗
Decision Date
November 29, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The axs infinity ls plus long sheath was cleared through the FDA 510(k) pathway on November 29, 2019. Manufactured by Stryker Neurovascular, it is classified as a Class 2 device under product code DQY.
What It Is
The axs infinity ls plus long sheath is a long, flexible catheter designed to provide stable access to the venous system during neurovascular interventions. It is used to navigate through the vascular anatomy to deliver stents or other therapeutic devices. Its design allows for precise control and positioning within the venous system, which is crucial in complex procedures.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in the treatment of conditions like venous stenosis or thrombosis. It is typically employed in hospital settings by specialists such as interventional radiologists and neurosurgeons. The sheath's length and flexibility make it suitable for accessing difficult-to-reach areas in the venous system, especially in adult patients with complex vascular anatomies.
Indications for Use
The axs infinity ls plus long sheath is indicated for use in patients requiring venous stent placement, often due to conditions that cause narrowing or blockage of the veins. It assists in delivering stents to the target site within the venous system.
Practical Considerations
The device is available in various lengths to accommodate different patient anatomies and procedural requirements. It is compatible with a range of stents and other interventional devices. Clinicians should be familiar with its handling characteristics to ensure optimal performance during procedures.
Frequently Asked Questions
What is the axs infinity ls plus long sheath used for?
It is used to provide access to the venous system for the placement of stents and other therapeutic devices during neurovascular procedures.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stent placement, particularly in cases of venous stenosis or thrombosis.
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.