đź“‹ FDA Reference
mobicath bi-directional guiding sheath model 1000182-xxx
Great Batch Medical
Summary: The Mobicath Bi-Directional Guiding Sheath is a medical device used in interventional procedures to facilitate catheter navigation. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K101784 ↗
Decision Date
November 26, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Mobicath Bi-Directional Guiding Sheath was cleared through the FDA 510(k) pathway on November 26, 2010. It is manufactured by Great Batch Medical and is classified as a Class 2 device under product code DYB.
What It Is
The Mobicath Bi-Directional Guiding Sheath is a flexible, steerable sheath designed to aid in the navigation and placement of catheters during minimally invasive procedures. Its bi-directional steering capability allows for precise control and positioning, which is crucial in complex vascular or cardiac interventions. This device is typically used in conjunction with other interventional tools to enhance procedural efficiency and safety.
Clinical Applications
Commonly used in interventional cardiology and radiology, the Mobicath Bi-Directional Guiding Sheath is employed in procedures such as embolization, angioplasty, and stent placement. It is particularly useful in settings requiring precise catheter placement, such as in the treatment of aneurysms or vascular malformations. The device is suitable for adult patients undergoing these specialized procedures in hospital or outpatient settings.
Indications for Use
The FDA-cleared indications for the Mobicath Bi-Directional Guiding Sheath include its use in facilitating the placement of embolization coils and other interventional devices. It is intended for patients requiring vascular access and precise catheter navigation during minimally invasive procedures.
Practical Considerations
The Mobicath Bi-Directional Guiding Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and interventional tools. Clinicians should be familiar with the device's steering mechanism to maximize its utility during procedures.
Frequently Asked Questions
What is Mobicath Bi-Directional Guiding Sheath used for?
It is used to facilitate the navigation and placement of catheters during interventional procedures, such as embolization and angioplasty.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
It is indicated for use in facilitating the placement of embolization coils and other interventional devices in vascular procedures.
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.