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radial artery catherization set with integral needle protection model ra-04020-sp
Arrow Intl.
Summary: The radial artery catheterization set with integral needle protection is used for accessing the radial artery for various diagnostic and therapeutic procedures. It is primarily used by interventional cardiologists and anesthesiologists.
FDA Clearance Information
Pathway 510K
Number K021120 ↗
Decision Date May 2, 2002
Product Code DQY
Device Class Class 2
Evidence 0 studies
The radial artery catheterization set by Arrow Intl. was cleared through the FDA 510(k) pathway on May 2, 2002. It is a Class 2 medical device under product code DQY.
What It Is
This device is a catheterization set designed for radial artery access, featuring integral needle protection to enhance safety during insertion. It allows for the introduction of catheters into the arterial system, typically for monitoring blood pressure or obtaining arterial blood samples. The needle protection mechanism helps prevent needlestick injuries, which is crucial in clinical settings.
Clinical Applications
Commonly used in interventional cardiology and anesthesiology, this device is employed during procedures that require arterial access, such as coronary angiography or continuous blood pressure monitoring in critical care settings. It is suitable for adult patients requiring arterial line placement, often in operating rooms or intensive care units.
Indications for Use
The device is intended for use in patients who require radial artery access for diagnostic or therapeutic purposes. This includes conditions where continuous arterial pressure monitoring or frequent arterial blood sampling is necessary.
Practical Considerations
The device typically comes in various sizes to accommodate different patient anatomies. Clinicians should ensure compatibility with other equipment used in arterial line setups. Proper technique in radial artery puncture is essential to minimize complications.
Frequently Asked Questions
What is the radial artery catheterization set used for?
It is used for accessing the radial artery for diagnostic and therapeutic procedures such as blood pressure monitoring and blood sampling.
What specialties typically use this device?
Interventional cardiologists and anesthesiologists commonly use this device in settings like operating rooms and intensive care units.
What are the FDA-cleared indications?
The device is indicated for radial artery access in patients needing diagnostic or therapeutic interventions involving arterial pressure monitoring or blood sampling.
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.