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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 ?
510(k)
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.
FDA-Cleared Indications
- Measurement of intravascular pressure during catheterization procedures.
- Use when intravascular pressure monitoring is needed during a catheter-based diagnostic or therapeutic procedure.
Clinical Applications
- Intravascular pressure measurement during diagnostic catheterization.
- Hemodynamic monitoring during catheter-based cardiovascular procedures.
- Pressure monitoring during interventional radiology procedures that require intravascular catheter access.
Practical Considerations
- The sheath size and length must match the planned vascular access site, catheter system, and patient anatomy.
- Confirm compatibility with the catheters, guidewires, connectors, and pressure-monitoring equipment used for the procedure.
- The device should be handled using sterile technique and prepared according to the manufacturer’s instructions.
- The record provided does not establish MRI safety; review the current manufacturer’s labeling before MRI exposure.
- General vascular-access risks include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and contrast-related complications when contrast is used.
Procedures that use this device
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.