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cardiosolutions dexterity steerable introducer
Cardiosolutions
Summary: The Cardiosolutions Dexterity Steerable Introducer is a medical device used in interventional cardiology for precise catheter placement. It is primarily used by cardiologists in procedures requiring vascular access.
FDA Clearance Information
Pathway
510K
Number
K140015 ↗
Decision Date
February 5, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cardiosolutions Dexterity Steerable Introducer was cleared through the FDA 510(k) pathway on February 5, 2014. It is manufactured by Cardiosolutions and is classified as a Class 2 device under product code DYB.
What It Is
The Cardiosolutions Dexterity Steerable Introducer is a device designed to facilitate the insertion and guidance of catheters into the vascular system. It features a steerable tip, allowing for precise navigation through the vasculature. This device is particularly useful in complex interventional procedures where accurate catheter placement is critical.
Clinical Applications
This device is commonly used in interventional cardiology, particularly during procedures such as embolization or other catheter-based interventions. It is utilized in hospital settings, often in catheterization labs, and is suitable for adult patients requiring vascular access for diagnostic or therapeutic purposes. Cardiologists and interventional radiologists are the primary users.
Indications for Use
The FDA-cleared indications for this device include its use in procedures that require the introduction and placement of catheters into the vascular system. It is intended for patients needing vascular access for treatments such as embolization.
Practical Considerations
The Dexterity Steerable Introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires. Clinicians should be familiar with the steering mechanism to optimize navigation and placement.
Frequently Asked Questions
What is the Cardiosolutions Dexterity Steerable Introducer used for?
It is used for the introduction and precise placement of catheters in the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring catheter introduction and placement in the vascular system, such as 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.