510(k) K262817

CrossFAST Integrated Microcatheter Advanced Delivery System by Vantis Vascular, Inc. — Product Code DQY

K262817 is an FDA 510(k) premarket notification submitted by Vantis Vascular, Inc. for the device "CrossFAST Integrated Microcatheter Advanced Delivery System". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Vantis Vascular, Inc. has at least 1 other 510(k) clearance on record.