HDF Assist Mudule, HDF Infusion Set and Substitution Filter
K-Number: K210575 · 2022-05-13
ApplicantNephros
Decision Date2022-05-13
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HDF Assist Mudule, HDF Infusion Set and Substitution Filter is a medical device manufactured by Nephros. It received FDA 510(k) clearance on 2022-05-13 under approval number K210575. 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 HDF Assist Mudule, HDF Infusion Set and Substitution Filter?
HDF Assist Mudule, HDF Infusion Set and Substitution Filter is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Nephros. The 510(k) number is K210575.
When was HDF Assist Mudule, HDF Infusion Set and Substitution Filter approved by the FDA?
HDF Assist Mudule, HDF Infusion Set and Substitution Filter received FDA 510(k) clearance on 2022-05-13, under approval number K210575.
What company makes HDF Assist Mudule, HDF Infusion Set and Substitution Filter?
HDF Assist Mudule, HDF Infusion Set and Substitution Filter is manufactured by Nephros.
What is the FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?
The FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter 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.