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cardiocurve steerable sheath small curl 40cm cc-1040s cardiocurve steerable sheath medium curl 40cm cc-1040m cardiocurve steerable sheath large curl 40cm cc-1040l cardiocurve steerable sheath small curl 61cm cc-1061s cardiocurve steerable sheath medium curl 61cm cc-1061m cardiocurve steerable sheath large curl 61cm cc-1061l cardiocurve steerable sheath small curl 71cm cc-1071s cardiocurve steerable sheath medium curl 71cm cc-1071m cardiocurve steer
Circa Scientific
Summary: The CardioCurve Steerable Sheath is a medical device used in interventional cardiology for precise catheter navigation. It is utilized by cardiologists in procedures such as embolization.
FDA Clearance Information
Pathway
510K
Number
K240004 ↗
Decision Date
January 31, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The CardioCurve Steerable Sheath by Circa Scientific was cleared through the FDA 510k pathway on January 31, 2024. It is classified as a Class 2 device under product code DYB.
What It Is
The CardioCurve Steerable Sheath is a flexible, steerable sheath designed to facilitate the navigation and placement of catheters within the cardiovascular system. It features various curl sizes and lengths to accommodate different anatomical and procedural needs. The device allows for enhanced control and precision during complex interventional procedures, making it a valuable tool in the cardiologist's arsenal.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in procedures involving embolization coils. It is suitable for use in hospital settings where precise catheter placement is critical. The sheath is designed for adult patients undergoing procedures that require detailed navigation through the vascular system, such as those with complex cardiac conditions.
Indications for Use
The FDA-cleared indications suggest that the CardioCurve Steerable Sheath is intended for use in procedures requiring the placement of embolization coils. It is suitable for patients needing precise catheter navigation within the cardiovascular system.
Practical Considerations
The device is available in multiple curl sizes and lengths, allowing for customization based on patient anatomy and procedural requirements. Clinicians should ensure compatibility with existing catheter systems and be familiar with the steering mechanism for optimal use.
Frequently Asked Questions
What is the CardioCurve Steerable Sheath used for?
It is used for precise catheter navigation and placement in interventional cardiology procedures, such as those involving embolization coils.
What specialties typically use this device?
Interventional cardiologists commonly use this device in hospital settings for complex cardiovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise catheter navigation and placement, particularly in the context of embolization.
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.