Outset Medical's TabloCart with Prefiltration Granted FDA 510(k) Clearance

Outset Medical, Inc has obtained FDA 510(k) clearance for TabloCartTM with prefiltration, an innovative accessory for their Tablo® Hemodialysis System. 

This clearance allows Outset to resume distribution of TabloCart with prefiltration across the United States.

The significance of this FDA clearance, highlighting how TabloCart enhances flexibility for healthcare providers—from ICU settings to bedside care. 

TabloCart offers two versions tailored to clinical needs: one with added storage capacity and another featuring water prefiltration capabilities. 

Key features include customizable prefiltration options to adapt to varying water conditions and enhanced maneuverability with 360-degree rotating wheels and directional locking rear wheels. 

This accessory complements the Tablo Hemodialysis System, known for simplifying dialysis both operationally for providers and experientially for patients, utilizing standard resources like tap water and electrical outlets.

This innovation underscores Outset Medical's commitment to advancing dialysis treatment through technology.

Outset Medical continues to lead in dialysis technology, enabling flexible, efficient care delivery across different healthcare environments.





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