510(k) K100425

HASKAL TORQUE DEVICE by Elcam Medical Acal — Product Code DQX

K100425 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "HASKAL TORQUE DEVICE". The FDA issued a decision of Substantially Equivalent on June 17, 2010. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Elcam Medical Acal has at least 10 other 510(k) clearances on record.