510(k) K213834

Cardio Flow Peripheral Guide Wire by Cardio Flow Inc., — Product Code DQX

K213834 is an FDA 510(k) premarket notification submitted by Cardio Flow Inc., for the device "Cardio Flow Peripheral Guide Wire". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Cardio Flow Inc., has at least 4 other 510(k) clearances on record.