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crossfast integrated microcatheter guide extension system cfm55
Vantis Vascular
Summary: The Crossfast Integrated Microcatheter Guide Extension System CFM55 is a medical device used in vascular procedures to assist in the placement of venous stents. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K242276 ↗
Decision Date
September 30, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Crossfast Integrated Microcatheter Guide Extension System CFM55, manufactured by Vantis Vascular, received FDA clearance via the 510k pathway on September 30, 2024. It is classified as a Class 2 device under product code DQY.
What It Is
The Crossfast Integrated Microcatheter Guide Extension System CFM55 is designed to facilitate the delivery and placement of venous stents. It integrates a microcatheter with a guide extension system, allowing for precise navigation through the vascular system. This device is particularly useful in complex vascular procedures where enhanced control and stability are required.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for procedures involving the placement of venous stents. It is suitable for use in hospitals and specialized clinics, and is often employed in treating patients with venous obstructions or other vascular conditions. The system's design aids in navigating challenging vascular anatomies, making it valuable in complex cases.
Indications for Use
The FDA-cleared indications for this device include its use in procedures that require the placement of venous stents. It is intended for patients with conditions such as venous obstructions or other vascular abnormalities that necessitate stenting.
Practical Considerations
The Crossfast system is typically compatible with a range of stent sizes and is designed to work with standard vascular access techniques. Clinicians should be familiar with microcatheter navigation and guide extension systems to optimize its use. Proper sizing and compatibility with existing stents and vascular anatomy are important considerations.
Frequently Asked Questions
What is the Crossfast Integrated Microcatheter Guide Extension System CFM55 used for?
It is used to assist in the delivery and placement of venous stents during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of venous stents, particularly in patients with venous obstructions or vascular abnormalities.
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.