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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-01-24 under 510(k) 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. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K213639.

When did Revaclear 500, Revaclear 400, Revaclear 300 receive FDA 510(k) clearance?

Revaclear 500, Revaclear 400, Revaclear 300 received FDA 510(k) clearance on 2022-01-24, under 510(k) number K213639.

Who is the listed applicant for Revaclear 500, Revaclear 400, Revaclear 300?

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 Revaclear 500, Revaclear 400, Revaclear 300?

The FDA product code for Revaclear 500, Revaclear 400, Revaclear 300 is KDI.

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Related Devices (Code: 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.

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