Outset Medical receives FDA 510(k) clearance for TabloCart with Prefiltration; resumes distribution

Outset Medical, Inc.

FDA granted 510(k) clearance for TabloCart with Prefiltration, an accessory for the Tablo Hemodialysis System.
Outset has resumed distribution and has product available to ship to U.S. customers.
TabloCart features three customizable prefiltration options and a booster pump for variable water conditions.
CEO Leslie Trigg states clearance enhances flexibility for nurses and health systems from ICU to bedside.

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