510(k) K152498

SoloPath Re-Collapsible Access System by Onset Medical Corporation — Product Code DYB

K152498 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 January 5, 2016. 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.