510(k) K201305

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain by Atrium Medical Corporation — Product Code CAC

K201305 is an FDA 510(k) premarket notification submitted by Atrium Medical Corporation for the device "Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain". The FDA issued a decision of Substantially Equivalent on September 3, 2021. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Atrium Medical Corporation has at least 5 other 510(k) clearances on record.