510(k) K100819

THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER by Onset Medical Corporation — Product Code DYB

K100819 is an FDA 510(k) premarket notification submitted by Onset Medical Corporation for the device "THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER". The FDA issued a decision of Substantially Equivalent on August 2, 2010. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Onset Medical Corporation has at least 7 other 510(k) clearances on record.