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510(k) Data Aggregation
K Number
K234123Device Name
Easi-Vue® embolic microspheres System
Manufacturer
Date Cleared
2024-02-13
(47 days)
Product Code
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
ABK Biomedical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Easi-Vue® embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.
Device Description
Easi-Vue embolic microspheres are biocompatible, radiopaque, non-compressible, non-resorbable glass microspheres. The Easi-Vue embolic microspheres are included with the Easi-Vue embolic microspheres System which is comprised of Easi-Vue embolic microspheres Delivery Device and the Easi-Vue embolic microspheres Refill Syringe. The Delivery Device provides for controlled and targeted delivery of imageable radiopaque microspheres contained in the Refill Syringe. The Easi-Vue® embolic microspheres System is offered in three sizes: 50um, 100μm, and 150μm to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1).
The Easi-Vue embolic microsphere System is sterile, single use, and available only for prescription use. The device is compatible with a catheter with minimum inner diameter of 0.021" and a length between 110-150 cm (as appropriate for the diameter of the intended treatment vessel).
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K Number
K220567Device Name
Easi-Vue embolic microspheres System
Manufacturer
Date Cleared
2022-09-07
(191 days)
Product Code
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
ABK Biomedical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Easi-Vue™ embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.
Device Description
Easi-Vue embolic microspheres are biocompatible, radiopaque, non-compressible, non-resorbable glass microspheres. The Easi-Vue embolic microspheres are included with the Easi-Vue embolic microspheres System which is comprised of Easi-Vue embolic microspheres Administration Kit and the Easi-Vue embolic microspheres Refill Syringe. The device utilizes the Administration Kit for controlled and targeted delivery of imageable radiopaque microspheres. The Easi-Vue™ embolic microspheres System is offered in three sizes: 50 um, and 150 um to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1).
The Easi-Vue™ embolic microsphere System is sterile, single use, and available only for prescription use. The device is compatible with a catheter with minimum inner diameter of 0.021'' and a length between 110-150 cm (as appropriate for the diameter of the intended treatment vessel).
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Ask a specific question about this device
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