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FDA 510(k)

EMBOZENE MICROSPHERES

K-Number: K132675 · 2013-10-03

ApplicantCelonova Biosciences, Inc.
Decision Date2013-10-03
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOZENE MICROSPHERES is the device name listed in this FDA 510(k) record. The listed applicant is Celonova Biosciences, Inc.. It received FDA 510(k) clearance on 2013-10-03 under 510(k) number K132675. 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 EMBOZENE MICROSPHERES?

EMBOZENE MICROSPHERES is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Celonova Biosciences, Inc.. The 510(k) number is K132675.

When did EMBOZENE MICROSPHERES receive FDA 510(k) clearance?

EMBOZENE MICROSPHERES received FDA 510(k) clearance on 2013-10-03, under 510(k) number K132675.

Who is the listed applicant for EMBOZENE MICROSPHERES?

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

What is the FDA product code for EMBOZENE MICROSPHERES?

The FDA product code for EMBOZENE 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.

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Other records listing Celonova Biosciences, 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.

K130307ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHEREK073417EMBOZENE MICROSPHERES

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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