Sapphire NC Plus
K-Number: K162209 · 2016-10-06
ApplicantOrbusneich Medical, Inc.
Decision Date2016-10-06
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sapphire NC Plus is a medical device manufactured by Orbusneich Medical, Inc.. It received FDA 510(k) clearance on 2016-10-06 under approval number K162209. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sapphire NC Plus?
Sapphire NC Plus is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Orbusneich Medical, Inc.. The 510(k) number is K162209.
When was Sapphire NC Plus approved by the FDA?
Sapphire NC Plus received FDA 510(k) clearance on 2016-10-06, under approval number K162209.
What company makes Sapphire NC Plus?
Sapphire NC Plus is manufactured by Orbusneich Medical, Inc..
What is the FDA product code for Sapphire NC Plus?
The FDA product code for Sapphire NC Plus is LOX.
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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.