Embosphere Microspheres
K-Number: K181300 · 2018-07-16
ApplicantBiosphere Medical, S.A.
Decision Date2018-07-16
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Embosphere Microspheres is a medical device manufactured by Biosphere Medical, S.A.. It received FDA 510(k) clearance on 2018-07-16 under approval number K181300. 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 2018-07-16. It is manufactured by Biosphere Medical, S.A.. The 510(k) number is K181300.
When was Embosphere Microspheres approved by the FDA?
Embosphere Microspheres received FDA 510(k) clearance on 2018-07-16, under approval number K181300.
What company makes Embosphere Microspheres?
Embosphere Microspheres is manufactured by Biosphere Medical, S.A..
What is the FDA product code for Embosphere Microspheres?
The FDA product code for Embosphere Microspheres is KRD.
Related Clinical Trials
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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.