Bearpac Gets 510(k) Clearance Allowing At-Home Use for Pleural Effusion Drainage System

December 2, 2020

Bearpac Medical has received 510(k) marketing clearance from the FDA for its Passio Pump Drainage System for home-based delivery of pleural effusion therapy.

The Passio system, which is used to remove excess fluids around the lung, is comprised of a catheter, a handheld pump control and a disposable collection kit that holds the drained fluid.

A common condition that affects more than 200,000 individuals in the U.S. each year, pleural effusion occurs when fluid builds up between lung tissue and the chest due to poor pumping by the heart or inflammation.

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