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m-bolus embolic microspheres
Scion Cardio-Vascular
Summary: The m-bolus embolic microspheres are used for embolization procedures to block blood flow to specific areas. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K052509 ↗
Decision Date
December 11, 2006
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The m-bolus embolic microspheres were cleared through the FDA 510k pathway on December 11, 2006. Manufactured by Scion Cardio-Vascular, this device is classified as Class 2 under product code HCG.
What It Is
The m-bolus embolic microspheres are small, biocompatible particles used in embolization procedures. They work by occluding blood vessels to reduce or stop blood flow to targeted areas, such as tumors or arteriovenous malformations. The microspheres are delivered via a catheter and are designed to be precise and effective in blocking blood supply.
Clinical Applications
These microspheres are commonly used in interventional radiology and vascular surgery to treat conditions like uterine fibroids, liver cancer, and arteriovenous malformations. They are particularly useful in minimally invasive procedures where precise embolization is required. The device is suitable for use in hospital settings, often in interventional suites or operating rooms.
Indications for Use
The FDA-cleared indications for the m-bolus embolic microspheres include the treatment of hypervascular tumors and arteriovenous malformations. They are used to block blood flow to these areas, helping to manage or shrink the affected tissues.
Practical Considerations
When using the m-bolus embolic microspheres, clinicians should consider the size of the microspheres to match the target vessel size. Compatibility with standard embolization catheters is generally expected. Technique considerations include ensuring accurate catheter placement for effective embolization.
Frequently Asked Questions
What is m-bolus embolic microspheres used for?
They are used for embolization to block blood flow to specific areas, such as tumors or malformations.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for treating hypervascular tumors and arteriovenous malformations by occluding 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.