510(k) K901565

ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE by Applied Vascular Devices, Inc. — Product Code DXC

K901565 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE". The FDA issued a decision of Substantially Equivalent on June 12, 1990. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.