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medamicus flowguard peelable introducer
Medamicus
Summary: The Medamicus FlowGuard Peelable Introducer is a medical device used to facilitate the insertion of catheters and other devices into the vascular system. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K030905 ↗
Decision Date
April 9, 2003
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medamicus FlowGuard Peelable Introducer was cleared through the FDA 510(k) pathway on April 9, 2003. 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 sheath introducer designed to provide a conduit for the insertion of catheters and other medical devices into the vascular system. It features a peelable design that allows for easy removal once the catheter is in place, minimizing trauma to the vessel. This device is typically used in procedures requiring vascular access, such as the placement of embolization coils.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures requiring vascular access. It is suitable for use in both inpatient and outpatient settings, and is often employed in the treatment of conditions such as aneurysms or vascular malformations. The introducer is particularly useful in patient populations requiring precise and minimally invasive vascular interventions.
Indications for Use
The FDA indications for the Medamicus FlowGuard Peelable Introducer include its use in facilitating the placement of embolization coils and other devices into the vascular system. It is intended for patients requiring vascular interventions, particularly those involving embolization procedures.
Practical Considerations
The device is available in various sizes to accommodate different catheter diameters and patient anatomies. It is compatible with a range of catheters and embolization devices. Clinicians should ensure proper technique during insertion to minimize vessel trauma and optimize procedural outcomes.
Frequently Asked Questions
What is the Medamicus FlowGuard Peelable Introducer used for?
It is used to facilitate the insertion of catheters and other devices into the vascular system, particularly for embolization 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 facilitating the placement of embolization coils and other devices into the vascular system.
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.