510(k) K040615

COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM by Advanced Vascular Dynamics — Product Code DXC

K040615 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 1, 2004. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Advanced Vascular Dynamics has at least 7 other 510(k) clearances on record.