510(k) K193279

Comet II Pressure Guidewire by Boston Scientific Corporation — Product Code DXO

K193279 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Comet II Pressure Guidewire". The FDA issued a decision of Substantially Equivalent on December 23, 2019. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.