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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 ?
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.
FDA-Cleared Indications
- Use during procedures that require intravascular pressure monitoring.
- Use to measure pressure within a blood vessel during catheter-based interventions.
- Use during embolization and other endovascular procedures when pressure assessment is needed.
Clinical Applications
- Intravascular pressure monitoring during embolization procedures.
- Pressure measurement during catheter-based vascular interventions.
- Hemodynamic assessment during selected interventional radiology and interventional cardiology procedures.
Practical Considerations
- The kit is available in different sheath sizes; selection depends on the access vessel, catheter system and procedure.
- The pressure-sensing system must be prepared, connected and calibrated according to the manufacturer’s instructions before use.
- It is intended for use with compatible catheterization and pressure-monitoring equipment; compatibility should be confirmed before the procedure.
- The record provided does not establish MRI safety. MRI compatibility should be verified in the current manufacturer’s labeling before scanning.
- As with other vascular access sheaths, use may be unsuitable or require special caution in patients with severe bleeding risk, local infection or inadequate access-vessel size.
Procedures that use this device
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.