510(k) K172458

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit by Smiths Medical Asd, Inc. — Product Code DRS

K172458 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit". The FDA issued a decision of Substantially Equivalent on November 9, 2017. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.