510(k) K261631

Amplatzer TorqVue Exchange System by Abbott Medical — Product Code DQY

K261631 is an FDA 510(k) premarket notification submitted by Abbott Medical for the device "Amplatzer TorqVue Exchange System". The FDA issued a decision of Substantially Equivalent on June 17, 2026. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Abbott Medical has at least 10 other 510(k) clearances on record.