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FDA 510(k)

Easi-Vue® embolic microspheres System

K-Number: K234123 · 2024-02-13

ApplicantAbk Biomedical, Inc.
Decision Date2024-02-13
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 2024-02-13 under 510(k) number K234123. 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 2024-02-13. The listed applicant is Abk Biomedical, Inc.. The 510(k) number is K234123.

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

Easi-Vue® embolic microspheres System received FDA 510(k) clearance on 2024-02-13, under 510(k) number K234123.

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.

K220567Easi-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

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

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