510(k) K260751

35 Helix Guidewire by Piraeus Medical, Inc. — Product Code MOF

K260751 is an FDA 510(k) premarket notification submitted by Piraeus Medical, Inc. for the device "35 Helix Guidewire". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Piraeus Medical, Inc. has at least 3 other 510(k) clearances on record.