510(k) K212696

Aspira Pleural Drainage System by Merit Medical Systems, Inc. — Product Code DWM

K212696 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Aspira Pleural Drainage System". The FDA issued a decision of Substantially Equivalent on March 3, 2023. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.