
Nxstage Medical, Inc.
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NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) is an FDA 510(k)-cleared medical device (K232803) manufactured by Nxstage Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 2024. Regulation: 8.