Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Abk Biomedical, Inc.. It received FDA 510(k) clearance on 2024-02-13 under approval 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. It is manufactured by Abk Biomedical, Inc.. The 510(k) number is K234123.

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

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

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

Related PubMed Literature

PMID: 40246727 [Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Abk Biomedical, Inc.

K220567Easi-Vue embolic microspheres System

Related Devices (Code: KRD)

K162373LC Bead LUMIBiocompatibles UK Limited K160219Hilal Embolization MicroCoilsCook Incorporated K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated K150876Bead BlockBiocompatibles UK , Ltd. K171946Gel-BeadVascular Solutions, Inc. K172372QuadraSphere MicrospheresBiosphere Medical, S.A.

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.

↑