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asahi sasuke
Asahi Intecc
Summary: The Asahi Sasuke 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
K182844 ↗
Decision Date
June 22, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Sasuke was cleared through the FDA 510(k) pathway on June 22, 2019. Manufactured by Asahi Intecc, it is classified as a Class 2 device under product code DQY.
What It Is
The Asahi Sasuke is a guidewire designed for use in venous stenting procedures. It aids in navigating through the venous system to reach target sites for stent placement. Made with advanced materials, it provides flexibility and support, crucial for maneuvering through complex vascular anatomy.
Clinical Applications
The Asahi Sasuke is commonly used in procedures to address venous obstructions, such as those caused by chronic venous insufficiency or post-thrombotic syndrome. It is typically employed in hospital settings by specialists in interventional radiology and vascular surgery. The device is suitable for adult patients who require venous stenting to restore proper blood flow.
Indications for Use
The FDA-cleared indications for the Asahi Sasuke involve its use in procedures requiring venous stenting. It is intended for patients with conditions that lead to narrowed or blocked veins, necessitating intervention to improve blood circulation.
Practical Considerations
The Asahi Sasuke is available in various sizes to accommodate different anatomical requirements. It is compatible with standard stenting equipment and requires familiarity with guidewire handling techniques for optimal use. Clinicians should ensure proper selection based on patient-specific vascular anatomy.
Frequently Asked Questions
What is Asahi Sasuke used for?
The Asahi Sasuke is used for navigating the venous system during stenting procedures to treat venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Asahi Sasuke.
What are the FDA-cleared indications?
The Asahi Sasuke is indicated for use in procedures requiring venous stenting to treat narrowed or blocked veins.
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.