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confida adaptive sheath
Medtronic
Summary: The Confida Adaptive Sheath is a medical device used primarily in interventional radiology and cardiology for procedures involving embolization coils. It is utilized by specialists to facilitate the delivery of therapeutic devices to target sites within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K152054 ↗
Decision Date
August 7, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Confida Adaptive Sheath by Medtronic was cleared through the FDA 510(k) pathway on August 7, 2015. It is classified as a Class 2 device under product code DYB.
What It Is
The Confida Adaptive Sheath is a flexible, catheter-like device designed to assist in the delivery of embolization coils and other therapeutic devices to specific sites within the vascular system. It features an adaptive design that allows for ease of navigation through the vascular anatomy, providing clinicians with enhanced control and precision during procedures. This device is particularly useful in complex interventions where access to target sites is challenging.
Clinical Applications
The Confida Adaptive Sheath is commonly used in interventional radiology and cardiology settings, particularly for procedures involving the placement of embolization coils to treat vascular abnormalities such as aneurysms or arteriovenous malformations. It is suitable for use in both adult and pediatric populations, and is often employed in hospital catheterization labs and specialized vascular centers. The device's adaptability makes it ideal for navigating tortuous vascular pathways.
Indications for Use
The FDA indications for the Confida Adaptive Sheath include its use in procedures that require the delivery of embolization coils to treat vascular conditions. It is intended for patients with conditions that necessitate precise placement of therapeutic devices within the vascular system.
Practical Considerations
The Confida Adaptive Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of embolization coils and other interventional devices. Clinicians should be familiar with its handling characteristics and ensure compatibility with other procedural tools.
Frequently Asked Questions
What is the Confida Adaptive Sheath used for?
The Confida Adaptive Sheath is used to facilitate the delivery of embolization coils and other devices to target sites within the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Confida Adaptive Sheath in procedures involving vascular interventions.
What are the FDA-cleared indications?
The FDA-cleared indications include the use of the Confida Adaptive Sheath for delivering embolization coils to treat vascular conditions such as aneurysms or arteriovenous malformations.
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.