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510(k) Data Aggregation
K Number
K133447Device Name
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
Manufacturer
CELONOVA BIOSCIENCES, INC.
Date Cleared
2014-02-24
(104 days)
Product Code
NAJ, CON, EMB, KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
CELONOVA BIOSCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Embozene® Microspheres are intended for embolization of arteriovenous malformations, and hypervascular tumors, including uterine fibroids.
Device Description
Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as a hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of the different sizes. Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes or vials are available in 1 ml or 2 ml microsphere volume.
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K Number
K130307Device Name
ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE
Manufacturer
CELONOVA BIOSCIENCES, INC.
Date Cleared
2013-03-04
(25 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
CELONOVA BIOSCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ONCOZENE™ Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
Device Description
ONCOZENE™ Microspheres are precise dimensioned, soft, deformable microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). ONCOZENE™ Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The fully polymerized microspheres are compressible to enable smooth delivery through the indicated delivery catheter. ONCOZENE™ Microspheres contain no added dyes and are visually opaque. ONCOZENE™ Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Available as 40μm, 75μm and 100μm microsphere diameter sizes, the ONCOZENE™ syringes are available with 2ml or 3ml microsphere volume per syringe.
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K Number
K073417Device Name
EMBOZENE MICROSPHERES
Manufacturer
CELONOVA BIOSCIENCES, INC.
Date Cleared
2008-12-15
(377 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
CELONOVA BIOSCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations. Embozene™ Microspheres may be used for vasculturion of blood vessels within the neurovascular system.
Device Description
Celonova BioSciences, Inc. Embozene™ Microspheres are spherical embolic hydrogels. They are artificial embolization devices used to obstruct or reduce blood flow to hypervascularized tumors or artenovenous mall ormations via selective microcatheter delivery.
The embolization particles are available in seven (7) size ranges of 40, 100, 250, 400, 500, 700 and 900 um diameters to enable appropriate size selection for the turnor or malformation to be treated. Embozene™ Microspheres are designed for use under fluoroscopic guidance through compatible delivery catheters. The product is provided as a sterile, non pyrogenic, single use device. It is an uncolored or color-coded particle that is opaque under fluoroscopy. The product and its delivery container are steam sterlized.
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