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extra large check-flo introducer
Cook
Summary: The Extra Large Check-Flo Introducer by Cook is a medical device used for vascular access and catheter introduction. It's commonly used by interventional radiologists and cardiologists in procedures requiring large-bore access.
FDA Clearance Information
Pathway
510K
Number
K203670 ↗
Decision Date
February 16, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Extra Large Check-Flo Introducer was cleared via the FDA 510k pathway on February 16, 2021. Manufactured by Cook, it is classified as a Class 2 device under product code DYB.
What It Is
The Extra Large Check-Flo Introducer is a vascular access device designed to facilitate the introduction of catheters and other medical devices into the vascular system. It consists of a sheath and a dilator, allowing for smooth and controlled insertion. This device is particularly useful in procedures requiring large-bore access, ensuring minimal trauma to the vessel.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings. It is essential for procedures such as embolization, where large embolic devices or coils need to be introduced into the vasculature. The introducer is suitable for adult patients requiring large-bore vascular access, often in hospital or specialized clinic settings.
Indications for Use
The FDA-cleared indications for this device include use in procedures requiring the introduction of catheters into the vascular system. It is particularly indicated for patients needing embolization or other interventions involving large devices.
Practical Considerations
The Extra Large Check-Flo Introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and embolic devices. Clinicians should ensure proper technique to minimize vascular trauma and optimize procedural outcomes.
Frequently Asked Questions
What is the Extra Large Check-Flo Introducer used for?
It is used for vascular access and the introduction of catheters and other devices into the vascular system, particularly in procedures requiring large-bore access.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital and specialized clinic settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the introduction of catheters into the vascular system, such as embolization involving large devices.
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.