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FDA 510(k)

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504

K-Number: K233159 · 2023-12-01

Decision Date2023-12-01
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2023-12-01 under approval number K233159. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504?

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K233159.

When was pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 approved by the FDA?

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 received FDA 510(k) clearance on 2023-12-01, under approval number K233159.

What company makes pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504?

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504?

The FDA product code for pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 is KPO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.