510(k) K100319

MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L by Merit Medical Systems, Inc. — Product Code DTL

K100319 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L". The FDA issued a decision of Substantially Equivalent on April 28, 2010. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.