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Vascular Solutions
Summary: The Supercross Microcatheter is a medical device used in vascular interventions, primarily by interventional radiologists and cardiologists, to navigate complex vasculature. It is designed for use in procedures involving venous stents.
FDA Clearance Information
Pathway 510K
Number K210647 ↗
Decision Date April 30, 2021
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Supercross Microcatheter was cleared through the FDA 510(k) pathway on April 30, 2021. It is manufactured by Vascular Solutions and is classified as a Class 2 medical device.
What It Is
The Supercross Microcatheter is a specialized catheter designed to navigate the intricate pathways of the vascular system. It features a flexible, small-diameter design that allows it to reach difficult-to-access areas within blood vessels. This device is particularly useful in procedures requiring precision and control, such as the placement of venous stents.
Clinical Applications
The Supercross Microcatheter is commonly used in interventional radiology and cardiology settings. It is ideal for procedures that require the placement of stents in venous systems, such as treating venous obstructions or thrombosis. The device is used in hospitals and specialized clinics, often in patients with complex vascular conditions that necessitate precise intervention.
Indications for Use
The FDA indications suggest that the Supercross Microcatheter is intended for use in procedures involving venous stents. This means it is suitable for patients who require stenting to address venous blockages or other related conditions.
Practical Considerations
The Supercross Microcatheter is available in various sizes to accommodate different anatomical needs and is compatible with standard guidewires and stent delivery systems. Clinicians should be familiar with catheter navigation techniques to optimize its use in complex vascular procedures.
Frequently Asked Questions
What is the Supercross Microcatheter used for?
The Supercross Microcatheter is used for navigating complex vascular pathways and is primarily utilized in procedures involving the placement of venous stents.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Supercross Microcatheter in vascular intervention procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving venous stents, suitable for treating venous obstructions 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.