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modification to medamicus flowguard peelable introducer
Medamicus
Summary: The Medamicus FlowGuard Peelable Introducer is a medical device used to facilitate the insertion of catheters or other devices into the vascular system. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K040150 ↗
Decision Date
February 18, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medamicus FlowGuard Peelable Introducer was cleared through the FDA 510(k) pathway on February 18, 2004. It is manufactured by Medamicus and classified as a Class 2 device under product code DYB.
What It Is
The Medamicus FlowGuard Peelable Introducer is a specialized medical device designed to aid in the insertion of catheters into the vascular system. It features a peelable sheath that allows for easy removal once the catheter is in place, minimizing trauma to the vessel. This device is particularly useful in procedures requiring precise catheter placement and is designed to maintain vascular integrity during insertion.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where precise catheter placement is crucial. It is suitable for use in hospital settings, particularly in catheterization labs. The device is used in adult and pediatric populations requiring vascular access for diagnostic or therapeutic procedures.
Indications for Use
The FDA-cleared indications for the Medamicus FlowGuard Peelable Introducer include its use in facilitating the insertion of catheters into the vascular system. It is intended for patients requiring vascular access for procedures such as embolization.
Practical Considerations
The Medamicus FlowGuard Peelable Introducer is available in various sizes to accommodate different catheter diameters. It is compatible with standard catheterization techniques and requires careful handling to ensure the sheath peels away smoothly without damaging the catheter or vessel.
Frequently Asked Questions
What is the Medamicus FlowGuard Peelable Introducer used for?
It is used to facilitate the insertion of catheters into the vascular system, particularly in procedures requiring precise placement.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter insertion into the vascular system, particularly for procedures like embolization.
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.