510(k) K070485

BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L by Cardiva Medical, Inc. — Product Code DXC

K070485 is an FDA 510(k) premarket notification submitted by Cardiva Medical, Inc. for the device "BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L". The FDA issued a decision of Substantially Equivalent on Mar 22, 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.