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endophys pressure sensing sheath kit
Endophys
Summary: The Endophys Pressure Sensing Sheath Kit is a medical device used to measure intravascular pressure during catheter-based procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K141275 ↗
Decision Date
January 7, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Endophys Pressure Sensing Sheath Kit was cleared through the FDA 510(k) pathway on January 7, 2015. Manufactured by Endophys, it is classified as a Class 2 device under product code DYB.
What It Is
The Endophys Pressure Sensing Sheath Kit is designed to facilitate the measurement of intravascular pressures during catheterization procedures. It integrates pressure sensing capabilities within the sheath, allowing for real-time pressure monitoring without the need for separate pressure transducers. This can enhance procedural efficiency and accuracy in measuring hemodynamic parameters.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures that require precise hemodynamic monitoring, such as angioplasty or embolization. It is suitable for use in hospitals and specialized cardiac centers, catering to adult patients undergoing diagnostic or therapeutic catheterization procedures.
Indications for Use
The FDA-cleared indications for this device include its use in measuring intravascular pressures during catheter-based procedures. It is intended for patients undergoing procedures where accurate pressure monitoring is critical, such as in the management of cardiovascular conditions.
Practical Considerations
Clinicians should consider the compatibility of the sheath with existing catheter systems and ensure proper sizing to match patient anatomy. The integration of pressure sensing within the sheath may reduce the need for additional equipment, streamlining the procedure.
Frequently Asked Questions
What is the Endophys Pressure Sensing Sheath Kit used for?
It is used for measuring intravascular pressures during catheter-based procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for measuring intravascular pressures during catheterization 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.