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Crossfast Integrated Microcatheter Guide Extension System CFM55
Product: CrossFAST(TM) — all models and sizes
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 ?
510(k)
Number ?
K242276 ↗
Decision Date ?
September 30, 2024
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For use in procedures involving the delivery and placement of venous stents.
- Intended for percutaneous vascular procedures requiring catheter-based access and support for venous stent placement.
Clinical Applications
- Supporting delivery of venous stents in the iliac veins.
- Supporting delivery of venous stents in central veins.
- Assisting catheter navigation through challenging venous anatomy during venous stenting.
- Providing additional support and stability during percutaneous venous stent placement.
Practical Considerations
- Confirm compatibility between the CFM55, the selected venous stent, guidewire, introducer sheath and the target vessel anatomy before use.
- The operator should be familiar with percutaneous venous access, microcatheter navigation and guide-extension catheter handling.
- Use appropriate imaging guidance, typically fluoroscopy with contrast venography or other suitable vascular imaging.
- The record provided does not specify the device's MRI labeling, so MRI safety should be confirmed in the current instructions for use before scanning.
- Potential contraindications and warnings depend on the current manufacturer labeling, including unsuitable vascular anatomy, incompatible equipment or inability to obtain safe vascular access.
Procedures that use this device
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.