510(k) K131332

CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER by Cardiosolutions, Inc. — Product Code DYB

K131332 is an FDA 510(k) premarket notification submitted by Cardiosolutions, Inc. for the device "CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on July 19, 2013. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cardiosolutions, Inc. has at least 4 other 510(k) clearances on record.