510(k) K181031

TSI Transseptal Introducer by Pressure Products Medical Device Manufacturing, LLC — Product Code DYB

K181031 is an FDA 510(k) premarket notification submitted by Pressure Products Medical Device Manufacturing, LLC for the device "TSI Transseptal Introducer". The FDA issued a decision of Substantially Equivalent on October 26, 2018. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Pressure Products Medical Device Manufacturing, LLC has at least 8 other 510(k) clearances on record.