510(k) K121209

TERUMO PALL AL20X ARTERIAL FILTER by Terumo Cardiovascular Systems Corporation — Product Code DTM

K121209 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "TERUMO PALL AL20X ARTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on May 8, 2012. The device falls under product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line), a Class II device regulated under 21 CFR 870.4260. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.