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endophys pressure sensing sheath kit
Endophys Holdings
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
K180620 ↗
Decision Date
October 12, 2018
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 October 12, 2018. It is manufactured by Endophys Holdings and classified as a Class II device under product code DYB.
What It Is
The Endophys Pressure Sensing Sheath Kit is designed to provide real-time pressure measurements within blood vessels during catheterization procedures. It integrates pressure sensing technology into a sheath, allowing for continuous 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 such as angioplasty or stent placement. It is beneficial in scenarios where precise pressure monitoring is critical, such as in patients with complex cardiovascular conditions. The device is suitable for use in hospitals and specialized cardiac care centers.
Indications for Use
The Endophys Pressure Sensing Sheath Kit is indicated for use in patients undergoing catheter-based procedures where intravascular pressure monitoring is necessary. It is particularly useful in managing conditions that require precise hemodynamic assessment.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard catheterization equipment, making it easy to integrate into existing procedural workflows. Clinicians should be familiar with sheath insertion techniques to ensure optimal performance.
Frequently Asked Questions
What is the Endophys Pressure Sensing Sheath Kit used for?
It is used for real-time intravascular pressure monitoring during catheter-based procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in catheter-based procedures requiring intravascular pressure monitoring.
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.