510(k) K012520

GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E by Cardiac Assist Devices, Inc. — Product Code DRF

K012520 is an FDA 510(k) premarket notification submitted by Cardiac Assist Devices, Inc. for the device "GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E". The FDA issued a decision of Substantially Equivalent on March 27, 2002. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Cardiac Assist Devices, Inc. has at least 2 other 510(k) clearances on record.