510(k) K190098

Endophys Pressure Sensing Sheath by Endophys Holdings, LLC — Product Code DYB

K190098 is an FDA 510(k) premarket notification submitted by Endophys Holdings, LLC for the device "Endophys Pressure Sensing Sheath". The FDA issued a decision of Substantially Equivalent on March 7, 2019. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Endophys Holdings, LLC has at least 3 other 510(k) clearances on record.