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guider softip guiding catheter xf 5f
Boston Scientific, Target
Summary: The Guider Softip Guiding Catheter XF 5F is a medical device used in vascular procedures, primarily by interventional cardiologists and radiologists. It facilitates the placement of interventional devices within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K010853 ↗
Decision Date
April 18, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guider Softip Guiding Catheter XF 5F was cleared via the FDA 510(k) pathway on April 18, 2001. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DQY.
What It Is
The Guider Softip Guiding Catheter XF 5F is a flexible catheter designed to provide support and guidance for interventional devices during vascular procedures. It features a soft tip to minimize trauma to the vessel walls. The catheter is typically used to navigate through the vascular system to reach target sites for diagnostic or therapeutic interventions.
Clinical Applications
This guiding catheter is commonly used in interventional cardiology and radiology for procedures such as angioplasty or stent placement. It is particularly useful in navigating complex vascular anatomies and is employed in both coronary and peripheral vascular interventions. The device is suitable for use in hospitals and specialized cardiovascular centers, catering to adult patients with vascular conditions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring vascular access and guidance for other interventional tools. It is suitable for patients undergoing diagnostic or therapeutic vascular interventions.
Practical Considerations
The Guider Softip Guiding Catheter XF 5F is typically available in various lengths to accommodate different patient anatomies. It is compatible with standard interventional tools and requires careful handling to ensure precise navigation and placement. Clinicians should be familiar with catheter manipulation techniques to optimize procedural outcomes.
Frequently Asked Questions
What is the Guider Softip Guiding Catheter XF 5F used for?
It is used to provide support and guidance for interventional devices during vascular procedures, such as angioplasty or stent placement.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular access and guidance for interventional tools during diagnostic or therapeutic procedures.
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.