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flextra steerable introducer
Rhythm Xience, Inc. (Rxi)
Summary: The Flextra Steerable Introducer is a medical device used to facilitate the placement of embolization coils in vascular procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K170373 ↗
Decision Date
February 27, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Flextra Steerable Introducer was cleared through the FDA 510(k) pathway on February 27, 2017. It is manufactured by Rhythm Xience, Inc. and is classified as a Class 2 device under product code DYB.
What It Is
The Flextra Steerable Introducer is a specialized catheter designed to aid in the precise placement of embolization coils during vascular interventions. Its steerable design allows for enhanced maneuverability and control within the vasculature, making it easier to navigate complex anatomical pathways. This device is particularly useful in procedures requiring high precision, such as those involving the treatment of aneurysms or arteriovenous malformations.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Flextra Steerable Introducer is employed in procedures that require the delivery of embolization coils to specific vascular sites. It is often used in hospital settings, particularly in catheterization labs, where precision and control are paramount. The device is suitable for adult patients undergoing embolization procedures to treat conditions like aneurysms or to control bleeding.
Indications for Use
The FDA indications for the Flextra Steerable Introducer include its use in facilitating the placement of embolization coils in the vasculature. This means it is intended for patients who require embolization procedures, often to treat vascular abnormalities or to control bleeding.
Practical Considerations
The Flextra Steerable Introducer is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard embolization coils and requires familiarity with catheter-based techniques for optimal use. Clinicians should be trained in the use of steerable catheters to maximize the device's benefits.
Frequently Asked Questions
What is the Flextra Steerable Introducer used for?
The Flextra Steerable Introducer is used to facilitate the placement of embolization coils in vascular procedures, aiding in the treatment of conditions like aneurysms.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Flextra Steerable Introducer in procedures requiring precise vascular access and coil placement.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of embolization coils within the vasculature, often for treating vascular abnormalities or controlling bleeding.
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.