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asahi fubuki 043 asahi fubuki
Asahi Intecc
Summary: The Asahi Fubuki 043 is a medical device used in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K141981 ↗
Decision Date
March 9, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Fubuki 043 received FDA clearance through the 510(k) pathway on March 9, 2015. Manufactured by Asahi Intecc, it is classified as a Class 2 device under product code DQY.
What It Is
The Asahi Fubuki 043 is a guide catheter designed to facilitate the delivery of stents and other interventional devices to venous sites. It features a flexible yet supportive structure that aids in navigating complex venous anatomy. This device is particularly useful in procedures requiring precise placement and stability within the venous system.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Asahi Fubuki 043 is employed in procedures addressing venous stenosis or occlusions. It is suitable for use in hospital settings, especially in catheterization labs, where it assists in the placement of venous stents in patients with conditions like deep vein thrombosis or post-thrombotic syndrome.
Indications for Use
The FDA indications for the Asahi Fubuki 043 involve its use in procedures requiring venous stenting. It is intended for patients with venous blockages or narrowing that need intervention to restore proper blood flow.
Practical Considerations
The Asahi Fubuki 043 is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of stents and interventional tools, and clinicians should ensure proper sizing and technique to optimize outcomes.
Frequently Asked Questions
What is Asahi Fubuki 043 used for?
The Asahi Fubuki 043 is used for delivering stents and other devices in venous stenting 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 venous stenting procedures to treat venous obstructions or narrowing.
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.