đź“‹ FDA Reference
contour se microspheres syringe
Boston Scientific
Summary: The Contour SE Microspheres Syringe is a medical device used for embolization procedures. It is typically utilized by interventional radiologists to treat conditions such as uterine fibroids and arteriovenous malformations.
FDA Clearance Information
Pathway
510K
Number
K032707 ↗
Decision Date
September 23, 2003
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Contour SE Microspheres Syringe was cleared through the FDA 510(k) pathway on September 23, 2003. It is manufactured by Boston Scientific and is classified as a Class 2 medical device.
What It Is
The Contour SE Microspheres Syringe is designed for embolization, a procedure that blocks blood flow to specific areas. The device consists of biocompatible microspheres that are injected into the bloodstream to occlude blood vessels. This technique is often used to reduce blood supply to tumors or to control bleeding.
Clinical Applications
This device is commonly used in interventional radiology for procedures like uterine artery embolization to treat fibroids, and in the management of arteriovenous malformations. It is also used in oncology to restrict blood flow to tumors. The device is typically used in hospital settings, catering to adult patients who require minimally invasive treatment options.
Indications for Use
The FDA indications for the Contour SE Microspheres Syringe involve its use in embolization procedures to block blood vessels. It is suitable for patients with conditions such as uterine fibroids or certain types of tumors where reducing blood supply can be beneficial.
Practical Considerations
The microspheres come in various sizes to accommodate different vessel diameters, ensuring effective embolization. Compatibility with standard embolization catheters is essential, and the technique requires careful imaging guidance to ensure precise delivery.
Frequently Asked Questions
What is Contour SE Microspheres Syringe used for?
It is used for embolization procedures to block blood vessels in conditions like uterine fibroids and tumors.
What specialties typically use this device?
Interventional radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for embolization to occlude blood vessels in conditions such as uterine fibroids and certain tumors.
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.