510(k) K181001

Medtronic Confida Brecker Guidewire by Medtronic Core Valve, LLC — Product Code DQX

K181001 is an FDA 510(k) premarket notification submitted by Medtronic Core Valve, LLC for the device "Medtronic Confida Brecker Guidewire". The FDA issued a decision of Substantially Equivalent on May 3, 2018. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Medtronic Core Valve, LLC has 1 other 510(k) clearance on record.