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multiflex steerable sheath
Vizaramed
Summary: The Multiflex Steerable Sheath by Vizaramed is a Class 2 medical device used in interventional radiology and cardiology for precise catheter navigation. It is primarily utilized by specialists in procedures involving embolization coils.
FDA Clearance Information
Pathway 510K
Number K221655 ↗
Decision Date November 14, 2022
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Multiflex Steerable Sheath was cleared through the FDA 510k pathway on November 14, 2022. Manufactured by Vizaramed, it is classified as a Class 2 device under product code DYB.
What It Is
The Multiflex Steerable Sheath is a medical device designed to facilitate the navigation of catheters within the vasculature. Its steerable design allows for precise control and maneuverability, which is crucial during complex interventional procedures. The sheath is compatible with various catheter sizes, enhancing its versatility in clinical settings.
Clinical Applications
This device is commonly used in interventional radiology and cardiology, particularly in procedures that require the deployment of embolization coils. It is suitable for use in hospitals and specialized clinics, aiding in the treatment of vascular abnormalities such as aneurysms or arteriovenous malformations. The device is typically employed in adult patients, although it may also be used in pediatric cases depending on the clinical scenario.
Indications for Use
The FDA indicates this device for use in procedures requiring precise catheter placement, such as those involving embolization coils. It is intended for patients with vascular conditions that necessitate such interventions.
Practical Considerations
The Multiflex Steerable Sheath is available in various sizes to accommodate different catheter dimensions. It is important to ensure compatibility with the catheters being used. Clinicians should be familiar with the device's steering mechanism to optimize procedural outcomes.
Frequently Asked Questions
What is the Multiflex Steerable Sheath used for?
It is used to navigate catheters during interventional procedures, particularly those involving embolization coils.
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 use in procedures requiring precise catheter placement, such as those involving embolization coils.
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.