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resposable omni tip tm switchable tips multiple
Trimedyne
Summary: The Resposable Omni Tip TM Switchable Tips by Trimedyne are used in portal vein procedures. They are typically utilized by interventional radiologists and vascular surgeons for precise interventions.
FDA Clearance Information
Pathway
510K
Number
K964585 ↗
Decision Date
April 17, 1997
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 17, 1997. Manufactured by Trimedyne, it is classified as a Class 2 device under product code GEX.
What It Is
The Resposable Omni Tip TM Switchable Tips are specialized medical devices designed for use in portal vein interventions. These tips can be switched during procedures, allowing for flexibility and precision. They are part of a broader category of devices used to access and treat conditions related to the portal vein, providing clinicians with tools to perform minimally invasive procedures.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, these tips are employed in procedures involving the portal vein, such as portal vein embolization or transjugular intrahepatic portosystemic shunt (TIPS) creation. They are suitable for adult patients requiring interventions in the portal venous system, often in hospital or specialized clinical settings.
Indications for Use
The device is indicated for use in procedures involving the portal vein, which may include treatment of portal hypertension or other related conditions. It is designed to aid in the precise delivery of therapeutic agents or devices within the portal venous system.
Practical Considerations
These tips are typically compatible with a range of catheter systems, offering versatility in different procedural settings. Clinicians should consider the specific size and compatibility with existing equipment when planning procedures. Proper technique is essential to ensure optimal outcomes and minimize complications.
Frequently Asked Questions
What is Resposable Omni Tip TM Switchable Tips used for?
It is used for portal vein interventions, such as embolization or TIPS procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is cleared for use in procedures involving the portal vein, addressing conditions like portal hypertension.
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.