510(k) K003452

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D by Ep Technologies, Inc. — Product Code DRF

K003452 is an FDA 510(k) premarket notification submitted by Ep Technologies, Inc. for the device "POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D". The FDA issued a decision of Substantially Equivalent on December 7, 2000. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Ep Technologies, Inc. has at least 10 other 510(k) clearances on record.