510(k) K233397

Cosine-10TM Diagnostic Catheter by Medtronic, Inc. — Product Code DRF

K233397 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Cosine-10TM Diagnostic Catheter". The FDA issued a decision of Substantially Equivalent on December 2, 2023. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Medtronic, Inc. has at least 10 other 510(k) clearances on record.