đź“‹ FDA Reference
Sentron Pressure Measuring Cath Pressure Interface
Summary: The Sentron Pressure Measuring Cath Pressure Interface by Cordis is a medical device used for measuring pressure in various clinical settings. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K864320 ↗
Decision Date ?
February 20, 1987
Product Code ?
DRQ
Device Class ?
Class 2
Evidence ?
0 studies
The Sentron Pressure Measuring Cath Pressure Interface was cleared through the FDA 510k pathway on February 20, 1987. Manufactured by Cordis, it is classified as a Class 2 device under product code DRQ.
What It Is
The Sentron Pressure Measuring Cath Pressure Interface is a device designed to measure pressure within the cardiovascular system. It works by interfacing with a catheter to provide real-time pressure readings, which are crucial for diagnosing and managing various cardiovascular conditions. The device is particularly useful in procedures that require precise pressure measurement, such as cardiac catheterizations.
FDA-Cleared Indications
- Measurement of pressure within the cardiovascular system.
- Use during procedures requiring cardiovascular pressure monitoring.
Clinical Applications
- Measuring cardiovascular pressure during cardiac catheterization.
- Monitoring pressure during catheter-based cardiovascular diagnostic procedures.
- Providing pressure measurements during angiographic procedures when cardiovascular pressure assessment is required.
Practical Considerations
- Use only with compatible catheterization and pressure-monitoring equipment, following the manufacturer’s instructions.
- The pressure-monitoring system should be properly assembled, flushed, zeroed, and calibrated before measurements are taken.
- Maintain sterile technique for any components that enter or connect to the sterile procedural field.
- The available record does not establish MRI safety; do not assume the device is MR safe or MR conditional without current manufacturer labeling.
- Use is subject to the risks and contraindications of the connected catheter and the cardiovascular procedure.
Frequently Asked Questions
What is Sentron Pressure Measuring Cath Pressure Interface used for?
It is used for measuring pressure within the cardiovascular system during diagnostic and interventional procedures.
What specialties typically use this device?
Cardiology and interventional radiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for pressure measurement in the cardiovascular system, particularly during procedures like cardiac catheterization.
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.