ABK Biomedical Incorporated

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Vascular, For Promoting Embolization (KRD) (6)

Premarket Exempt

Clear

Easi-Vue embolic microspheres System - 00850042341018 Catalog Number : EVA50

Device Class : 2

Duns Number: 203463617

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Easi-Vue embolic microspheres System - 00850042341025 Catalog Number : EVA100

Device Class : 2

Duns Number: 203463617

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Easi-Vue embolic microspheres System - 00850042341032 Catalog Number : EVA150

Device Class : 2

Duns Number: 203463617

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Easi-Vue embolic microspheres System - 00850042341049 Catalog Number : EVR50

Device Class : 2

Duns Number: 203463617

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Easi-Vue embolic microspheres System - 00850042341056 Catalog Number : EVR100

Device Class : 2

Duns Number: 203463617

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Easi-Vue embolic microspheres System - 00850042341063 Catalog Number : EVR150

Device Class : 2

Duns Number: 203463617

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

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