Easi-Vue embolic microspheres System

FDA UDI

Class II (US FDA UDI)

by ABK Biomedical Incorporated

Identity

Trade Name: Easi-Vue embolic microspheres System FDA UDI
Generic Name: Embolization particle, non-bioabsorbable FDA UDI
Model / Reference: Administration Kit 100 micron FDA UDI

Identifiers

Catalog Number: EVA100 FDA UDI
Primary DI / UDI-DI: 00850042341025 FDA UDI
510(k) Number: K220567 FDA UDI
FDA Product Code: KRD FDA UDI
GMDN Term: Embolization particle, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3300 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Easi-Vue embolic microspheres System by ABK Biomedical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K220567 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: ABK Biomedical Incorporated

Sources (1)

FDA UDI 336e9356-510a-4651-bfa9-301064a16b41 36 fields · synced May 30, 2026