510(k) K250031

Amplatzer Guidewire by ABBOTT MEDICAL — Product Code DQX

K250031 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Amplatzer Guidewire". The FDA issued a decision of Substantially Equivalent on October 3, 2025. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.