510(k) K260168

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) by Skycade Med Corporation — Product Code DQX

K260168 is an FDA 510(k) premarket notification submitted by Skycade Med Corporation for the device "Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330.