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FDA 510(k)

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)

K-Number: K232803 · 2024-03-14

ApplicantNxstage Medical, Inc.
Decision Date2024-03-14
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is a medical device manufactured by Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2024-03-14 under approval number K232803. 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 NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)?

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is a medical device that received FDA 510(k) clearance on 2024-03-14. It is manufactured by Nxstage Medical, Inc.. The 510(k) number is K232803.

When was NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) approved by the FDA?

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) received FDA 510(k) clearance on 2024-03-14, under approval number K232803.

What company makes NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)?

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is manufactured by Nxstage Medical, Inc..

What is the FDA product code for NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)?

The FDA product code for NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is KDI.

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Other Devices by Nxstage Medical, Inc.

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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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