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unitips
Unisurge
Summary: The unitips is a Class 2 medical device used in procedures involving the portal vein. It is typically utilized by interventional radiologists and surgeons.
FDA Clearance Information
Pathway
510K
Number
K930809 ↗
Decision Date
August 10, 1993
Product Code
GCJ
Device Class
Class 2
Evidence
0 studies
The unitips by Unisurge was cleared via the FDA 510k pathway on August 10, 1993. It is classified as a Class 2 device under product code GCJ.
What It Is
The unitips is a medical device designed for use in procedures involving the portal vein. It is typically used to facilitate access and intervention in the portal venous system. The device is engineered to be compatible with standard interventional techniques, providing reliable performance in complex vascular procedures.
Clinical Applications
Unitips is commonly used in interventional radiology and surgical settings, particularly in procedures involving the portal vein such as transjugular intrahepatic portosystemic shunt (TIPS) creation. It is suitable for use in patients with conditions like portal hypertension or cirrhosis, where portal vein access is necessary. The device is often employed in hospital settings, catering to adult and geriatric patient populations.
Indications for Use
The FDA-cleared indications for unitips involve its use in procedures requiring access to the portal vein. This is particularly relevant for patients with liver conditions that necessitate intervention in the portal venous system.
Practical Considerations
The unitips is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard vascular access equipment. Clinicians should be familiar with portal vein anatomy and interventional techniques to optimize device use.
Frequently Asked Questions
What is unitips used for?
Unitips is used for accessing the portal vein in procedures like TIPS creation, particularly in patients with portal hypertension.
What specialties typically use this device?
Interventional radiologists and surgeons commonly use unitips in procedures involving the portal venous system.
What are the FDA-cleared indications?
Unitips is indicated for use in accessing the portal vein, particularly in patients with conditions requiring portal venous intervention.
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.