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bioset xc
Regeneration Technologies
Summary: The bioset xc is a Class 2 medical device used in embolization procedures. It is typically utilized by interventional radiologists to treat conditions involving abnormal blood vessels.
FDA Clearance Information
Pathway
510K
Number
K060180 ↗
Decision Date
September 6, 2006
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The bioset xc was cleared through the FDA 510k pathway on September 6, 2006. It is manufactured by Regeneration Technologies and classified as a Class 2 device under product code MBP.
What It Is
The bioset xc is a type of embolization microsphere used in minimally invasive procedures to block blood flow to specific areas. These microspheres are injected into the bloodstream and lodge in small blood vessels, effectively cutting off circulation to targeted tissues, such as tumors or arteriovenous malformations. This device is designed to be biocompatible and is used to achieve precise embolization with minimal side effects.
Clinical Applications
The bioset xc is commonly used in interventional radiology for procedures such as uterine fibroid embolization, treatment of hypervascular tumors, and management of arteriovenous malformations. It is particularly useful in oncology for reducing blood supply to tumors, thereby shrinking them or making them more amenable to surgical removal. The device is typically used in hospital settings where interventional radiology services are available.
Indications for Use
The FDA has cleared the bioset xc for use in embolization procedures, which involve blocking blood vessels to treat conditions like tumors or vascular malformations. It is indicated for patients who require targeted blood flow reduction to specific areas.
Practical Considerations
The bioset xc comes in various sizes to accommodate different vessel diameters and procedural needs. It is important to select the appropriate size for effective embolization. Compatibility with standard catheter systems is generally expected, and clinicians should be familiar with catheter-based delivery techniques.
Frequently Asked Questions
What is bioset xc used for?
The bioset xc is used for embolization procedures to block blood flow to specific areas, such as tumors or vascular malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device in procedures requiring precise embolization.
What are the FDA-cleared indications?
The device is cleared for use in embolization procedures to treat conditions like tumors and vascular malformations by blocking blood vessels.
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.