📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access during interventional procedures.
- Real-time measurement and monitoring of intravascular pressure during vascular procedures.
- Use in procedures such as embolization when pressure monitoring is required.
Clinical Applications
- Providing vascular access while monitoring pressure during embolization procedures.
- Monitoring hemodynamic changes during interventional radiology procedures.
- Supporting pressure assessment during catheter-based vascular interventions.
- Providing access and pressure monitoring during procedures involving the abdominal or pelvic vasculature.
Practical Considerations
- The listed device is 8 French; the sheath size must be compatible with the planned catheter, guidewire and vascular access site.
- Use requires connection to a compatible pressure-monitoring system and appropriate pressure-transducer setup.
- The operator should confirm device compatibility, flush the system according to the instructions for use and remove air before pressure measurement.
- The available FDA record or supplied information does not establish MRI safety; MRI use should be avoided unless the current labeling specifically identifies the device as MR Safe or MR Conditional.
- Contraindications, warnings, sterility, storage and handling requirements should be taken from the current manufacturer labeling. General vascular-access risks include bleeding, hematoma, infection, thrombosis, vessel injury and contrast-related complications.
Procedures that use this device
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.