đź“‹ FDA Reference
supercross microcatheter 130 cm supercross microcatheter 150 cm model 5300 5301
Vascular Solutions
Summary: The Supercross Microcatheter is a specialized device used in interventional radiology and cardiology for accessing and navigating complex vascular pathways. It is primarily used by interventional specialists to assist in the placement of stents and other devices.
FDA Clearance Information
Pathway 510K
Number K101659 ↗
Decision Date December 16, 2010
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Supercross Microcatheter, manufactured by Vascular Solutions, was cleared via the FDA 510(k) pathway on December 16, 2010. It is a Class 2 medical device with the product code DQY.
What It Is
The Supercross Microcatheter is a flexible, small-diameter catheter designed for navigating tortuous vascular anatomy. It is available in lengths of 130 cm and 150 cm, allowing for access to distal vascular sites. The device is used to facilitate the delivery of therapeutic devices, such as stents, within the venous system.
Clinical Applications
This microcatheter is commonly used in interventional radiology and cardiology procedures, particularly for patients requiring venous stenting. It is suitable for use in hospital settings, especially in catheterization labs, where precision in navigating complex vascular pathways is critical. The device is often used in adult patients with conditions necessitating the placement of venous stents.
Indications for Use
The FDA indications suggest that the Supercross Microcatheter is intended for use in procedures involving the placement of venous stents. It is designed to help clinicians access challenging vascular regions and facilitate the delivery of stents to treat venous obstructions.
Practical Considerations
The Supercross Microcatheter is available in two lengths, 130 cm and 150 cm, to accommodate different anatomical needs. It is compatible with standard guidewires and is designed for use with other interventional devices. Clinicians should be familiar with microcatheter navigation techniques to optimize its use.
Frequently Asked Questions
What is the Supercross Microcatheter used for?
The Supercross Microcatheter is used for navigating complex vascular pathways and assisting in the delivery of stents and other therapeutic devices in the venous system.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in procedures involving vascular access and stenting.
What are the FDA-cleared indications?
The device is cleared for use in procedures that require the placement of venous stents, particularly in complex vascular anatomy.
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.