đź“‹ FDA Reference
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 ?
510(k)
Number ?
K021120 ↗
Decision Date ?
May 2, 2002
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheterization of the radial artery for diagnostic or therapeutic procedures.
- Introduction of a catheter into the arterial system through radial artery access.
Clinical Applications
- Establishing radial artery access for diagnostic arterial procedures.
- Establishing radial artery access for therapeutic arterial procedures.
- Obtaining arterial blood samples through a radial arterial catheter.
- Providing radial arterial access for arterial pressure monitoring when clinically indicated.
Practical Considerations
- Confirm the catheter and needle dimensions are appropriate for the patient's anatomy and the intended arterial-line or catheter system.
- Verify compatibility with guidewires, pressure-monitoring tubing, connectors and other equipment used in the arterial access setup.
- Use sterile technique and appropriate radial artery puncture technique to reduce bleeding, infection, thrombosis and nerve or vascular injury.
- The integral needle-protection mechanism is intended to reduce needlestick risk; it does not replace standard sharps handling and disposal procedures.
- MRI safety depends on the materials and configuration of the specific set and any catheter left in place. Review the current manufacturer labeling before MRI, and do not assume the device is MR safe or MR conditional.
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.