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acuity tm cut-away tm guide catheters 6f and 8f
Boston Scientific
Summary: The Acuity Cut-Away Guide Catheters are used in interventional cardiology for venous access and stent placement. They are primarily utilized by cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K111252 ↗
Decision Date
June 2, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Acuity Cut-Away Guide Catheters, manufactured by Boston Scientific, were cleared through the FDA 510(k) pathway on June 2, 2011. They are classified as Class 2 medical devices.
What It Is
The Acuity Cut-Away Guide Catheters are specialized catheters designed to provide access to the venous system, facilitating the delivery of stents and other interventional devices. Available in 6F and 8F sizes, these catheters feature a cut-away design that aids in precise navigation and placement within the vascular system. They are typically used in conjunction with imaging techniques to guide procedures.
Clinical Applications
These guide catheters are commonly used in interventional cardiology, particularly for procedures involving venous stent placement. They are essential in settings such as cardiac catheterization labs, where precise vascular access is required. The catheters are suitable for adult patients undergoing complex venous interventions, often in cases of venous obstructions or anomalies.
Indications for Use
The FDA-cleared indications for the Acuity Cut-Away Guide Catheters include their use in facilitating the placement of venous stents. They are intended for patients requiring interventional treatment of venous conditions, such as blockages or structural abnormalities.
Practical Considerations
These catheters are available in 6F and 8F sizes, making them versatile for different patient anatomies. Compatibility with standard interventional tools is a key consideration, and clinicians should be familiar with catheter handling and navigation techniques to optimize outcomes.
Frequently Asked Questions
What is Acuity Cut-Away Guide Catheters used for?
They are used for providing venous access and facilitating the placement of stents during interventional cardiology procedures.
What specialties typically use this device?
Interventional cardiologists primarily use these catheters in catheterization labs.
What are the FDA-cleared indications?
The catheters are indicated for use in procedures requiring venous access and stent placement, particularly in cases of venous blockages or structural issues.
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.