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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
K160272 ↗
Decision Date
March 4, 2016
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 March 4, 2016. 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 a specialized medical device designed to provide real-time pressure measurements within blood vessels during catheterization procedures. It integrates a pressure sensor within the sheath, allowing for continuous monitoring of hemodynamic parameters without the need for additional equipment. This can enhance procedural efficiency and safety by providing immediate feedback to the clinician.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures such as angioplasty, stent placement, and embolization. It is beneficial in scenarios where precise pressure monitoring is critical, such as in patients with complex cardiovascular conditions. The device is typically used in hospital catheterization labs by specialists trained in endovascular techniques.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring intravascular pressure monitoring, such as during embolization and other catheter-based interventions. It is suitable for patients undergoing these procedures who require accurate and continuous pressure assessment.
Practical Considerations
The Endophys Pressure Sensing Sheath Kit is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard catheterization equipment and requires no special training beyond typical catheterization techniques. Clinicians should ensure proper calibration of the pressure sensor before use.
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 primarily use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring intravascular pressure monitoring, such as embolization and other catheter-based interventions.
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.