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unipearls r embolic microspheres
Suzhou Haowei Medical Technology
Summary: The unipearls r embolic microspheres are used for embolization procedures to occlude blood vessels. They are typically utilized by interventional radiologists in various vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K231554 ↗
Decision Date
November 14, 2023
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The unipearls r embolic microspheres were cleared through the FDA 510k pathway on November 14, 2023. Manufactured by Suzhou Haowei Medical Technology, this device is classified as a Class 2 medical device.
What It Is
The unipearls r embolic microspheres are small, spherical particles designed for use in embolization procedures. These microspheres are introduced into the vascular system to occlude blood vessels, thereby reducing or stopping blood flow to a targeted area. This can be useful in treating conditions such as tumors or arteriovenous malformations by depriving them of their blood supply.
Clinical Applications
Clinically, unipearls r embolic microspheres are used in interventional radiology for procedures like uterine fibroid embolization, treatment of hypervascular tumors, and management of gastrointestinal bleeding. They are typically used in hospital settings by specialists trained in minimally invasive vascular procedures. The device is suitable for adult patients who require targeted vessel occlusion.
Indications for Use
The FDA indications for unipearls r embolic microspheres include use in embolization procedures to occlude blood vessels. This is applicable for patients with conditions that benefit from reduced blood flow, such as certain tumors or vascular abnormalities.
Practical Considerations
When using unipearls r embolic microspheres, clinicians should consider the size of the microspheres relative to the target vessels. Compatibility with delivery catheters and the specific embolization technique are important factors to ensure effective and safe use.
Frequently Asked Questions
What is unipearls r embolic microspheres used for?
Unipearls r embolic microspheres are used for embolization procedures to occlude blood vessels, often in the treatment of tumors or vascular malformations.
What specialties typically use this device?
Interventional radiologists typically use this device in hospital settings for minimally invasive vascular procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in embolization procedures to occlude blood vessels, particularly for conditions that benefit from reduced blood flow.
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.