đź“‹ FDA Reference
sentron pressure measuring cath pressure interface
Cordis
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
510K
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.
Clinical Applications
This device is commonly used in cardiology and interventional radiology for procedures like cardiac catheterization and angiography. It is essential in settings where accurate pressure measurement is critical, such as in the diagnosis and treatment of heart disease. The device is typically used in hospitals and specialized cardiac care centers, catering to adult and pediatric patient populations.
Indications for Use
The FDA indications suggest that this device is used for measuring pressure in the cardiovascular system. It is suitable for patients undergoing procedures that require precise pressure monitoring, such as those with suspected or known cardiovascular conditions.
Practical Considerations
The device is compatible with standard catheterization equipment and is available in various sizes to accommodate different patient anatomies. Clinicians should ensure proper calibration before use to maintain accuracy. It is important to follow aseptic techniques during insertion to prevent infections.
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.