510(k) K244061

X-Wire Guidewire by Imperative Care, Inc. — Product Code MOF

K244061 is an FDA 510(k) premarket notification submitted by Imperative Care, Inc. for the device "X-Wire Guidewire". The FDA issued a decision of Substantially Equivalent on August 26, 2025. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Imperative Care, Inc. has at least 10 other 510(k) clearances on record.