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FDA 510(k)

Embosphere Microspheres

K-Number: K250971 · 2025-05-16

ApplicantBiosphere Medical, S.A.
Decision Date2025-05-16
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Embosphere Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Biosphere Medical, S.A.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K250971. 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 Embosphere Microspheres?

Embosphere Microspheres is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Biosphere Medical, S.A.. The 510(k) number is K250971.

When did Embosphere Microspheres receive FDA 510(k) clearance?

Embosphere Microspheres received FDA 510(k) clearance on 2025-05-16, under 510(k) number K250971.

Who is the listed applicant for Embosphere Microspheres?

The FDA 510(k) record lists Biosphere Medical, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Embosphere Microspheres?

The FDA product code for Embosphere Microspheres is KRD.

Related Clinical Trials

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.

NCT05112926Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee OsteoarthritisCOMPLETED

Other records listing Biosphere Medical, S.A. 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.

K192480Torpedo Gelatin FoamK183120EmboCube Embolization GelatinK183578Torpedo Gelatin FoamK181021EmboCube Embolization GelatinK181300Embosphere MicrospheresK172372QuadraSphere Microspheres

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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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