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finecross m3
Ashitaka Factory Of Terumo
Summary: The Finecross M3 is a medical device used primarily in interventional cardiology and radiology for venous stenting. It is designed for use by healthcare professionals specializing in vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K203521 ↗
Decision Date
March 3, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Finecross M3 was cleared through the FDA 510k pathway on March 3, 2021. It is manufactured by the Ashitaka Factory Of Terumo and classified as a Class 2 device under product code DQY.
What It Is
The Finecross M3 is a specialized microcatheter used in the placement of venous stents. It facilitates the navigation and delivery of stents within the vascular system, particularly in complex or tortuous anatomy. The device is designed to enhance precision and control during interventional procedures, providing clinicians with a reliable tool for managing venous obstructions.
Clinical Applications
The Finecross M3 is commonly used in procedures involving the placement of venous stents, such as in the treatment of venous insufficiency or occlusions. It is utilized in interventional cardiology and radiology settings, often in hospitals or specialized vascular centers. The device is suitable for adult patients with conditions requiring venous stenting, and it is particularly useful in cases where vascular access is challenging.
Indications for Use
The FDA-cleared indications for the Finecross M3 involve its use in the placement of stents within the venous system. It is intended for patients with venous blockages or narrowing that require stenting to restore proper blood flow.
Practical Considerations
The Finecross M3 is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard stenting equipment and requires careful handling to ensure precise placement. Clinicians should be familiar with microcatheter techniques and the specific procedural protocols for venous stenting.
Frequently Asked Questions
What is Finecross M3 used for?
The Finecross M3 is used for the placement of venous stents to treat blockages or narrowing in the venous system.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the Finecross M3 in vascular intervention procedures.
What are the FDA-cleared indications?
The device is indicated for use in the placement of venous stents to address venous obstructions or insufficiencies.
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.