đź“‹ FDA Reference
asahi precious guide catheter
Asahi Intecc
Summary: The Asahi Precious Guide Catheter is a medical device used in interventional cardiology and radiology for guiding stents and other devices into the vasculature. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K061601 ↗
Decision Date
November 17, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Precious Guide Catheter was cleared through the FDA 510(k) pathway on November 17, 2006. It is manufactured by Asahi Intecc and classified as a Class 2 device under product code DQY.
What It Is
The Asahi Precious Guide Catheter is a flexible tube designed to facilitate the delivery of interventional devices such as stents into the vascular system. It provides support and guidance during procedures, ensuring accurate placement of therapeutic devices. Its design allows for easy navigation through the vasculature, minimizing trauma to the vessel walls.
Clinical Applications
This device is commonly used in procedures involving the placement of venous stents, particularly in the context of treating vascular diseases. It is utilized in interventional cardiology and radiology settings, often in hospitals and specialized clinics. Patients with conditions such as coronary artery disease or peripheral vascular disease may benefit from procedures involving this catheter.
Indications for Use
The Asahi Precious Guide Catheter is indicated for use in patients requiring the placement of venous stents. It is suitable for conditions where vascular access and device delivery are necessary, aiding in the treatment of vascular obstructions.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of interventional devices, and clinicians should be familiar with its handling and insertion techniques to optimize outcomes.
Frequently Asked Questions
What is the Asahi Precious Guide Catheter used for?
It is used to guide and support the placement of stents and other interventional devices into the vascular system.
What specialties typically use this device?
Interventional cardiologists and radiologists primarily use this device in vascular procedures.
What are the FDA-cleared indications?
The catheter is indicated for use in procedures requiring the placement of venous stents, particularly in treating vascular obstructions.
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.