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510(k) Data Aggregation
K Number
K231554Device Name
UniPearls® Embolic Microspheres
Manufacturer
Date Cleared
2023-11-14
(168 days)
Product Code
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Haowei Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UniPearls® Embolic Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
Device Description
UniPearls® Embolic Microspheres consist of non-biodegradable hydrogel microspheres packaged in a 10 ml penicillin bottle. The penicilin bottle contains 1 ml of spheres suspended in 7 ml of physiological saline or 2 ml of spheres suspended in 6 ml of physiological saline. UniPearls® Embolic Microspheres are offered in seven sizes: 70μm, 400μm, 500μm, 700μm and 1000μm. The spheres are available in two colors: colorless and blue. The spheres are intended to be used with an inner diameter that is adequate for sphere delivery (not included). The finished by steam and is intended for single use only.
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