510(k) K090286

PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE by Advanced Vascular Dynamics — Product Code DXC

K090286 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE". The FDA issued a decision of Substantially Equivalent on March 23, 2009. 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.