510(k) K242644

SENDERO MAX Delivery Catheter by Okami Medical, Inc. — Product Code DQY

K242644 is an FDA 510(k) premarket notification submitted by Okami Medical, Inc. for the device "SENDERO MAX Delivery Catheter". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Okami Medical, Inc. has at least 6 other 510(k) clearances on record.