Bearpac Medical’s Pleural Effusion Pump Gets 510(k) Clearance

Bearpac Medical has gained 510(k) clearance from the FDA for its Passio pump drainage system, a device designed for removing fluid from the lungs.

The system has been cleared for treating patients with malignant and symptomatic pleural effusions. The Class II electronic, handheld pump provides controlled delivery of therapy.

Using a disposable collection kit, the user attaches the pump to an implanted catheter designed exclusively for use with the device and activates it to begin fluid collection.