đź“‹ FDA Reference
modification to contour se microspheres
Boston Scientific
Summary: Contour SE Microspheres are used for embolization procedures to block blood flow to specific areas, often in interventional radiology. They are typically used by clinicians in settings like hospitals and specialized clinics.
FDA Clearance Information
Pathway
510K
Number
K032542 ↗
Decision Date
September 16, 2003
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Contour SE Microspheres were cleared through the FDA 510(k) pathway on September 16, 2003. Manufactured by Boston Scientific, this device is classified as Class 2 under product code HCG.
What It Is
Contour SE Microspheres are small, spherical particles used in embolization procedures to occlude blood vessels. They are designed to be delivered via a catheter to block blood flow to targeted areas, such as tumors or arteriovenous malformations. The microspheres are made from a biocompatible material that allows them to be safely used within the vascular system.
Clinical Applications
These microspheres are commonly used in interventional radiology for procedures such as uterine fibroid embolization, treatment of hypervascular tumors, and arteriovenous malformations. They are particularly useful in oncology for reducing blood supply to tumors, thereby limiting their growth. The device is typically used in hospital settings by interventional radiologists and vascular surgeons.
Indications for Use
The FDA indications for Contour SE Microspheres include embolization procedures where reducing or blocking blood flow is necessary. This is often applicable in cases like uterine fibroids, certain types of tumors, or vascular malformations.
Practical Considerations
Contour SE Microspheres come in various sizes to accommodate different vessel diameters and clinical needs. They are compatible with standard catheter systems used in embolization procedures. Clinicians should be familiar with catheterization techniques and the specific embolization protocol for each condition.
Frequently Asked Questions
What is Contour SE Microspheres used for?
Contour SE Microspheres are used to block blood flow in embolization procedures, often targeting tumors or abnormal blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital and specialized clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to reduce or block blood flow in conditions such as tumors and vascular malformations.
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.