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endophys pressure sensing sheath kit- 8f
Endophys Holdings
Summary: The Endophys Pressure Sensing Sheath Kit is a medical device used for real-time pressure monitoring during vascular procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K173399 ↗
Decision Date
November 30, 2017
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 November 30, 2017, by Endophys Holdings. 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 vascular access while simultaneously providing real-time pressure measurements. This device integrates a pressure sensor within the sheath, allowing clinicians to monitor hemodynamic parameters without the need for additional catheters. It is particularly useful in procedures where continuous pressure monitoring is critical.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures such as angioplasty or embolization where real-time pressure data is crucial. It is suitable for adult patients undergoing vascular interventions, providing clinicians with immediate feedback on hemodynamic changes.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring vascular access and pressure monitoring, such as embolization. It is intended for patients who need continuous hemodynamic assessment during these interventions.
Practical Considerations
The Endophys Pressure Sensing Sheath Kit typically comes in an 8 French size, making it compatible with a range of vascular access procedures. Clinicians should ensure compatibility with other devices used during the procedure and be familiar with the integration of pressure monitoring systems.
Frequently Asked Questions
What is the Endophys Pressure Sensing Sheath Kit used for?
It is used for vascular access and real-time pressure monitoring during procedures like angioplasty and embolization.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring vascular access and continuous pressure monitoring, such as 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.