510(k) K072297

BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM by Cardiva Medical, Inc. — Product Code DXC

K072297 is an FDA 510(k) premarket notification submitted by Cardiva Medical, Inc. for the device "BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 12, 2007. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Cardiva Medical, Inc. has 6 other 510(k) clearances on record.