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flexcath select steerable sheath 10 french
Medtronic Cryocath, Lp
Summary: The FlexCath Select Steerable Sheath is a 10 French medical device used in catheter-based procedures, primarily by cardiologists for electrophysiology studies and interventions.
FDA Clearance Information
Pathway
510K
Number
K142684 ↗
Decision Date
November 6, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The FlexCath Select Steerable Sheath was cleared via the FDA 510(k) pathway on November 6, 2014. Manufactured by Medtronic Cryocath, it is classified as a Class 2 device under product code DYB.
What It Is
The FlexCath Select Steerable Sheath is a 10 French sheath designed to facilitate the insertion and positioning of catheters within the cardiovascular system. Its steerable design allows for precise navigation through the vasculature, enhancing the ability to reach targeted areas during procedures. This device is particularly useful in electrophysiology, where accurate catheter placement is crucial for mapping and ablation.
Clinical Applications
This device is commonly used in electrophysiology labs during procedures such as catheter ablation for atrial fibrillation or other arrhythmias. Cardiologists and electrophysiologists utilize it to improve access and maneuverability within the heart's complex structures. It is suitable for adult patients undergoing these minimally invasive procedures in hospital settings.
Indications for Use
The FlexCath Select Steerable Sheath is indicated for use in patients requiring catheter-based interventions, particularly those involving the heart's electrical system. It is designed to aid in the delivery and positioning of diagnostic and therapeutic catheters.
Practical Considerations
The sheath's 10 French size is compatible with a range of catheters used in electrophysiology. Its steerable feature requires familiarity with manipulation techniques to optimize procedural outcomes. Clinicians should ensure compatibility with other procedural equipment.
Frequently Asked Questions
What is FlexCath Select Steerable Sheath used for?
It is used to facilitate the insertion and positioning of catheters during cardiovascular procedures, especially in electrophysiology.
What specialties typically use this device?
Cardiology and electrophysiology specialties typically use this device during catheter-based interventions.
What are the FDA-cleared indications?
It is indicated for use in catheter-based cardiovascular interventions, aiding in the delivery and positioning of catheters.
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.