Revaclear 500, Revaclear 400, Revaclear 300
K-Number: K213639 · 2022-01-24
ApplicantBaxter Healthcare Corporation
Decision Date2022-01-24
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Revaclear 500, Revaclear 400, Revaclear 300 is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-01-24 under approval number K213639. 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 Revaclear 500, Revaclear 400, Revaclear 300?
Revaclear 500, Revaclear 400, Revaclear 300 is a medical device that received FDA 510(k) clearance on 2022-01-24. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K213639.
When was Revaclear 500, Revaclear 400, Revaclear 300 approved by the FDA?
Revaclear 500, Revaclear 400, Revaclear 300 received FDA 510(k) clearance on 2022-01-24, under approval number K213639.
What company makes Revaclear 500, Revaclear 400, Revaclear 300?
Revaclear 500, Revaclear 400, Revaclear 300 is manufactured by Baxter Healthcare Corporation.
What is the FDA product code for Revaclear 500, Revaclear 400, Revaclear 300?
The FDA product code for Revaclear 500, Revaclear 400, Revaclear 300 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.