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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 the device name listed in this FDA 510(k) record. The listed applicant is Abk Biomedical, Inc.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) 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. The listed applicant is Abk Biomedical, Inc.. The 510(k) number is K220567.

When did Easi-Vue embolic microspheres System receive FDA 510(k) clearance?

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

Who is the listed applicant for Easi-Vue embolic microspheres System?

The FDA 510(k) record lists Abk Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Abk Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234123Easi-Vue® embolic microspheres System

Related Devices (Code: KRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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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