510(k) K203521

FineCross M3 by Ashitaka Factory Of Terumo Corporation — Product Code DQY

K203521 is an FDA 510(k) premarket notification submitted by Ashitaka Factory Of Terumo Corporation for the device "FineCross M3". The FDA issued a decision of Substantially Equivalent on Mar 3, 2021. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Ashitaka Factory Of Terumo Corporation has 2 other 510(k) clearances on record.