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check-flo performer introducer micropuncture radial artery access set
Cook
Summary: The Check-Flo Performer Introducer Micropuncture Radial Artery Access Set is a medical device used for gaining vascular access, particularly in interventional radiology and cardiology. It is primarily used by clinicians performing embolization procedures.
FDA Clearance Information
Pathway
510K
Number
K171609 ↗
Decision Date
June 4, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Check-Flo Performer Introducer Set by Cook was cleared through the FDA 510(k) pathway on June 4, 2018. It is classified as a Class 2 device under product code DYB.
What It Is
The Check-Flo Performer Introducer Set is designed for micropuncture access to the radial artery, facilitating the introduction of catheters and other devices into the vascular system. It includes a needle, guidewire, and introducer sheath, which work together to provide a minimally invasive entry point for vascular procedures. This device is crucial for reducing complications associated with larger bore access methods.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise vascular access is essential. It is particularly useful in settings where radial artery access is preferred, such as in patients with challenging femoral access or those at higher risk of bleeding. The device is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA-cleared indications for this device include its use in gaining access to the radial artery for the purpose of performing embolization procedures. It is intended for patients who require minimally invasive vascular access for therapeutic interventions.
Practical Considerations
The Check-Flo Performer Introducer Set is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheterization techniques and can be used in conjunction with other interventional devices. Clinicians should be trained in radial artery access techniques to optimize outcomes.
Frequently Asked Questions
What is the Check-Flo Performer Introducer Set used for?
It is used for gaining vascular access to the radial artery, primarily for embolization procedures in interventional radiology and cardiology.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device for vascular access during minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for gaining access to the radial artery for embolization procedures, providing a minimally invasive entry point for vascular interventions.
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.