510(k) K240864

PacePro Wire by Opsens, Inc. — Product Code DQX

K240864 is an FDA 510(k) premarket notification submitted by Opsens, Inc. for the device "PacePro Wire". The FDA issued a decision of Substantially Equivalent on May 24, 2024. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Opsens, Inc. has at least 10 other 510(k) clearances on record.