510(k) K062852

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 by Onset Medical Corporation — Product Code DYB

K062852 is an FDA 510(k) premarket notification submitted by Onset Medical Corporation for the device "BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870". The FDA issued a decision of Substantially Equivalent on February 23, 2007. 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.