510(k) K955847

GYRO TIP EP CATHETER by Cardiac Assist Devices, Inc. — Product Code DRF

K955847 is an FDA 510(k) premarket notification submitted by Cardiac Assist Devices, Inc. for the device "GYRO TIP EP CATHETER". The FDA issued a decision of Substantially Equivalent on January 29, 1997. 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.