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the arterial wand safety introducer with arterial catheter made of chronoflex c with bioguard technology
Access Scientific
Summary: The arterial wand safety introducer with arterial catheter is a medical device used for safe arterial access. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K181563 ↗
Decision Date
September 26, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 26, 2018, by Access Scientific. It is classified as a Class 2 device under the product code DQY.
What It Is
The arterial wand safety introducer with arterial catheter is designed to facilitate safe and efficient arterial access. Made of Chronoflex C with Bioguard technology, it provides enhanced durability and infection resistance. This device is particularly useful in procedures requiring arterial catheterization, offering a reliable means of introducing catheters into the arterial system.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, arterial pressure monitoring, and catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs and operating rooms, and is utilized in both emergency and elective procedures. The device is applicable to a wide range of patient populations requiring arterial access.
Indications for Use
The device is indicated for patients requiring arterial access for diagnostic or therapeutic procedures. It is suitable for conditions where arterial catheterization is necessary, such as in the management of cardiovascular diseases.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard arterial catheters and introducer sheaths. Clinicians should be familiar with the technique of arterial access to ensure optimal outcomes.
Frequently Asked Questions
What is the arterial wand safety introducer used for?
It is used for safe and efficient arterial access during diagnostic and therapeutic procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for arterial access in procedures requiring catheterization, such as angiography and pressure monitoring.
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.