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mobicath bi-directional guiding sheath
Great Batch Medical
Summary: The Mobicath Bi-Directional Guiding Sheath is a medical device used in interventional procedures to guide catheters into blood vessels. It is primarily used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K130559 ↗
Decision Date
May 24, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Mobicath Bi-Directional Guiding Sheath was cleared through the FDA 510k pathway on May 24, 2013. It is manufactured by Great Batch Medical and classified as a Class 2 device.
What It Is
The Mobicath Bi-Directional Guiding Sheath is a flexible tube designed to facilitate the insertion and navigation of catheters within the vascular system. It features bi-directional steering capabilities, allowing for precise control and positioning during procedures. This device is particularly useful in complex vascular interventions where access and maneuverability are critical.
Clinical Applications
This guiding sheath is commonly used in interventional cardiology and radiology procedures, such as embolization and catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs. The device is often employed in adult patients requiring precise catheter placement for diagnostic or therapeutic purposes.
Indications for Use
The FDA indications for the Mobicath Bi-Directional Guiding Sheath include its use in procedures involving embolization coils. It is intended for patients who require vascular access and catheter navigation for interventional treatments.
Practical Considerations
The Mobicath sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheters and embolization devices. Clinicians should be familiar with the bi-directional steering mechanism to optimize device performance during interventions.
Frequently Asked Questions
What is the Mobicath Bi-Directional Guiding Sheath used for?
It is used to guide catheters into blood vessels during interventional procedures, particularly for embolization and other vascular interventions.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving embolization coils, facilitating vascular access and catheter navigation.
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.