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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2021-10-19 under 510(k) 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. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K211035.

When did U9000 Plus Ultrafilter receive FDA 510(k) clearance?

U9000 Plus Ultrafilter received FDA 510(k) clearance on 2021-10-19, under 510(k) number K211035.

Who is the listed applicant for U9000 Plus Ultrafilter?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U9000 Plus Ultrafilter?

The FDA product code for U9000 Plus Ultrafilter is FIP.

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Related Devices (Code: 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.

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