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FDA 510(k)

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

K-Number: K232467 · 2023-09-14

ApplicantBaxter Healthcare Corporation
Decision Date2023-09-14
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2023-09-14 under approval number K232467. 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 CleanCart A, CleanCart C, AK 98 Hemodialysis Machine?

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K232467.

When was CleanCart A, CleanCart C, AK 98 Hemodialysis Machine approved by the FDA?

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine received FDA 510(k) clearance on 2023-09-14, under approval number K232467.

What company makes CleanCart A, CleanCart C, AK 98 Hemodialysis Machine?

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for CleanCart A, CleanCart C, AK 98 Hemodialysis Machine?

The FDA product code for CleanCart A, CleanCart C, AK 98 Hemodialysis Machine 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.

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