510(k) K121404

SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM by Onset Medical Corporation — Product Code DYB

K121404 is an FDA 510(k) premarket notification submitted by Onset Medical Corporation for the device "SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on May 3, 2013. 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.