510(k) K250075

Medtronic Stedi Extra Support Guidewire by Medtronic, Inc. — Product Code DQX

K250075 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Medtronic Stedi Extra Support Guidewire". The FDA issued a decision of Substantially Equivalent on June 13, 2025. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Medtronic, Inc. has at least 10 other 510(k) clearances on record.