Optiflux dialyzer
K-Number: K162488 · 2017-04-06
ApplicantFresenius Medical Care North America
Decision Date2017-04-06
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Optiflux dialyzer is a medical device manufactured by Fresenius Medical Care North America. It received FDA 510(k) clearance on 2017-04-06 under approval number K162488. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optiflux dialyzer?
Optiflux dialyzer is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Fresenius Medical Care North America. The 510(k) number is K162488.
When was Optiflux dialyzer approved by the FDA?
Optiflux dialyzer received FDA 510(k) clearance on 2017-04-06, under approval number K162488.
What company makes Optiflux dialyzer?
Optiflux dialyzer is manufactured by Fresenius Medical Care North America.
What is the FDA product code for Optiflux dialyzer?
The FDA product code for Optiflux dialyzer is KDI.
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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.