510(k) K090114

MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S by Oscor, Inc. — Product Code DYB

K090114 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S". The FDA issued a decision of Substantially Equivalent on June 4, 2009. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Oscor, Inc. has at least 10 other 510(k) clearances on record.