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precious plus guide catheter
Asahi Intecc
Summary: The Precious Plus Guide Catheter is a medical device used to facilitate the placement of stents in venous procedures. It is primarily used by interventional cardiologists and radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K072316 ↗
Decision Date
September 17, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Precious Plus Guide Catheter, manufactured by Asahi Intecc, received FDA clearance through the 510(k) pathway on September 17, 2007. It is classified as a Class 2 device under product code DQY.
What It Is
The Precious Plus Guide Catheter is a flexible tube designed to provide support and guidance for other devices, such as stents, during venous interventions. It is engineered to navigate the vascular system with precision, featuring a design that balances flexibility and support. This catheter is critical in procedures requiring access to specific venous sites, ensuring the accurate delivery of therapeutic devices.
Clinical Applications
This guide catheter is commonly used in interventional cardiology and radiology for procedures involving the placement of venous stents. It is particularly useful in treating conditions like venous obstructions or thrombosis. The device is typically employed in hospital settings, especially in catheterization labs, and is used on patients requiring vascular interventions to improve blood flow.
Indications for Use
The FDA-cleared indications for the Precious Plus Guide Catheter involve its use in procedures that require the placement of stents within the venous system. It is suitable for patients with conditions that necessitate the opening of blocked or narrowed veins.
Practical Considerations
When using the Precious Plus Guide Catheter, clinicians should consider the appropriate size for the specific procedure and patient anatomy. The device is compatible with a range of stents and should be handled with care to maintain its structural integrity during insertion and navigation.
Frequently Asked Questions
What is the Precious Plus Guide Catheter used for?
It is used to facilitate the placement of stents in venous interventions, particularly in treating venous obstructions.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of stents within the venous system to treat blockages or narrowings.
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.