QuadraSphere Microspheres
K-Number: K172372 · 2017-09-06
ApplicantBiosphere Medical, S.A.
Decision Date2017-09-06
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
QuadraSphere Microspheres is a medical device manufactured by Biosphere Medical, S.A.. It received FDA 510(k) clearance on 2017-09-06 under approval number K172372. 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 QuadraSphere Microspheres?
QuadraSphere Microspheres is a medical device that received FDA 510(k) clearance on 2017-09-06. It is manufactured by Biosphere Medical, S.A.. The 510(k) number is K172372.
When was QuadraSphere Microspheres approved by the FDA?
QuadraSphere Microspheres received FDA 510(k) clearance on 2017-09-06, under approval number K172372.
What company makes QuadraSphere Microspheres?
QuadraSphere Microspheres is manufactured by Biosphere Medical, S.A..
What is the FDA product code for QuadraSphere Microspheres?
The FDA product code for QuadraSphere Microspheres 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.