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tlab r transvenous liver biopsy system tf-18c
Argon Medical Devices
Summary: The tlab r transvenous liver biopsy system tf-18c is a medical device used for obtaining liver tissue samples via a transvenous approach. It is primarily used by interventional radiologists and hepatologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K241145 ↗
Decision Date August 1, 2024
Product Code DYB
Device Class Class 2
Evidence 0 studies
The tlab r transvenous liver biopsy system tf-18c received FDA clearance through the 510(k) pathway on August 1, 2024. It is manufactured by Argon Medical Devices and is classified as a Class 2 device under product code DYB.
What It Is
The tlab r transvenous liver biopsy system tf-18c is designed to facilitate liver biopsies through a transvenous route, which can be advantageous in patients with coagulopathy or other contraindications to percutaneous biopsy. The system typically includes a catheter and biopsy needle that can be navigated through the venous system to the liver, allowing for tissue sampling without direct puncture of the liver capsule.
Clinical Applications
This device is commonly used in interventional radiology and hepatology for patients requiring liver biopsy who are at high risk for bleeding or have ascites. It is particularly useful in hospital settings where imaging guidance is available. The device is suitable for adult patients with liver disease who need diagnostic evaluation or monitoring of liver conditions.
Indications for Use
The FDA-cleared indications for this device include obtaining liver tissue samples in patients where traditional percutaneous biopsy is contraindicated. It is used in conditions such as coagulopathy or when the liver is difficult to access percutaneously.
Practical Considerations
The device is typically compatible with standard imaging modalities such as ultrasound or fluoroscopy to guide the procedure. Clinicians should be familiar with transvenous biopsy techniques and consider patient-specific factors such as vascular anatomy and liver size when planning the procedure.
Frequently Asked Questions
What is tlab r transvenous liver biopsy system tf-18c used for?
It is used for obtaining liver tissue samples in patients where percutaneous biopsy is contraindicated.
What specialties typically use this device?
Interventional radiologists and hepatologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for liver biopsies in patients with contraindications to percutaneous biopsy, such as coagulopathy.
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.