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FDA 510(k)

Easi-Vue embolic microspheres System

K-Number: K220567 · 2022-09-07

ApplicantAbk Biomedical, Inc.
Decision Date2022-09-07
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Easi-Vue embolic microspheres System is a medical device manufactured by Abk Biomedical, Inc.. It received FDA 510(k) clearance on 2022-09-07 under approval number K220567. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Easi-Vue embolic microspheres System?

Easi-Vue embolic microspheres System is a medical device that received FDA 510(k) clearance on 2022-09-07. It is manufactured by Abk Biomedical, Inc.. The 510(k) number is K220567.

When was Easi-Vue embolic microspheres System approved by the FDA?

Easi-Vue embolic microspheres System received FDA 510(k) clearance on 2022-09-07, under approval number K220567.

What company makes Easi-Vue embolic microspheres System?

Easi-Vue embolic microspheres System is manufactured by Abk Biomedical, Inc..

What is the FDA product code for Easi-Vue embolic microspheres System?

The FDA product code for Easi-Vue embolic microspheres System is KRD.

Related Clinical Trials

NCT05112926 Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis ACTIVE_NOT_RECRUITING NCT07541404 MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma NOT_YET_RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING NCT06735833 MMA Embolization for Refractory Chronic Migraine RECRUITING NCT03731000 PHIL® Embolic System Pediatric IDE RECRUITING

Other Devices by Abk Biomedical, Inc.

K234123Easi-Vue® embolic microspheres System

Related Devices (Code: KRD)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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