EmboCube Embolization Gelatin
K-Number: K183120 · 2019-08-06
ApplicantBiosphere Medical, S.A.
Decision Date2019-08-06
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EmboCube Embolization Gelatin is a medical device manufactured by Biosphere Medical, S.A.. It received FDA 510(k) clearance on 2019-08-06 under approval number K183120. 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 EmboCube Embolization Gelatin?
EmboCube Embolization Gelatin is a medical device that received FDA 510(k) clearance on 2019-08-06. It is manufactured by Biosphere Medical, S.A.. The 510(k) number is K183120.
When was EmboCube Embolization Gelatin approved by the FDA?
EmboCube Embolization Gelatin received FDA 510(k) clearance on 2019-08-06, under approval number K183120.
What company makes EmboCube Embolization Gelatin?
EmboCube Embolization Gelatin is manufactured by Biosphere Medical, S.A..
What is the FDA product code for EmboCube Embolization Gelatin?
The FDA product code for EmboCube Embolization Gelatin is KRD.
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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.