U9000 Plus Ultrafilter
K-Number: K211035 · 2021-10-19
ApplicantBaxter Healthcare Corporation
Decision Date2021-10-19
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
U9000 Plus Ultrafilter is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2021-10-19 under approval number K211035. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the U9000 Plus Ultrafilter?
U9000 Plus Ultrafilter is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K211035.
When was U9000 Plus Ultrafilter approved by the FDA?
U9000 Plus Ultrafilter received FDA 510(k) clearance on 2021-10-19, under approval number K211035.
What company makes U9000 Plus Ultrafilter?
U9000 Plus Ultrafilter is manufactured by Baxter Healthcare Corporation.
What is the FDA product code for U9000 Plus Ultrafilter?
The FDA product code for U9000 Plus Ultrafilter is FIP.
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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.