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creganna-tactx steerable sheath set symmetric
Creganna Medical Devices
Summary: The Creganna-Tactx Steerable Sheath Set Symmetric is a medical device used in interventional procedures, primarily by cardiologists and interventional radiologists, to navigate and deliver embolization coils. It is designed to enhance precision and control during vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K131079 ↗
Decision Date
August 1, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Creganna-Tactx Steerable Sheath Set Symmetric was cleared via the FDA 510(k) pathway on August 1, 2013. Manufactured by Creganna Medical Devices, it is classified as a Class 2 device under product code DYB.
What It Is
The Creganna-Tactx Steerable Sheath Set Symmetric is a specialized catheter system designed to provide enhanced steerability and control during vascular interventions. It features a flexible, steerable tip that allows clinicians to navigate tortuous anatomy with precision. This device is particularly useful in procedures requiring the deployment of embolization coils, where accurate placement is critical.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly in procedures involving embolization, such as treating aneurysms or vascular malformations. It is suitable for use in both hospital and outpatient settings, and is typically employed in adult patients requiring precise vascular access and intervention. The steerable sheath is especially beneficial in complex cases where traditional catheters may not provide adequate control.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the delivery of embolization coils to targeted vascular sites. It is intended for patients who require embolization procedures, often due to aneurysms, arteriovenous malformations, or other vascular abnormalities.
Practical Considerations
The Creganna-Tactx Steerable Sheath Set 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 the steering mechanism to maximize the device's effectiveness and ensure patient safety.
Frequently Asked Questions
What is the Creganna-Tactx Steerable Sheath Set Symmetric used for?
It is used to facilitate the delivery of embolization coils during vascular interventions, providing enhanced control and precision.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures requiring precise vascular access and intervention.
What are the FDA-cleared indications?
The device is indicated for use in delivering embolization coils to targeted vascular sites, particularly in patients with vascular abnormalities such as aneurysms.
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.