đź“‹ FDA Reference
Tlab R Transvenous Liver Biopsy System Tf-18c
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 ?
510(k)
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.
FDA-Cleared Indications
- Obtaining liver tissue samples through a transvenous approach.
- Use when percutaneous liver biopsy is contraindicated or clinically unsuitable.
Clinical Applications
- Transjugular liver biopsy for diagnostic evaluation of liver disease.
- Liver tissue sampling in patients with coagulopathy or increased bleeding risk.
- Liver biopsy in patients with ascites or other factors that make percutaneous biopsy unsuitable.
- Image-guided liver biopsy performed through the venous system in a hospital or interventional radiology setting.
Practical Considerations
- The TF-18C is designed for transvenous access and should be used by clinicians trained in transjugular liver biopsy techniques.
- Fluoroscopy is typically used to guide venous catheterization and positioning; ultrasound may assist with vascular access and procedural planning.
- Patient-specific factors, including venous anatomy, hepatic anatomy, coagulopathy, thrombosis, infection risk, and liver size, should be assessed before the procedure.
- The record provided does not establish MRI safety, MRI conditional labeling, or compatibility with specific MRI environments; consult the current manufacturer instructions for use.
- Use, storage, preparation, needle handling, and compatibility with access equipment should follow the current Argon Medical Devices instructions for use.
Procedures that use this device
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.