510(k) K260292

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) by Atraverse Medical — Product Code DXF

K260292 is an FDA 510(k) premarket notification submitted by Atraverse Medical for the device "HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)". The FDA issued a decision of Substantially Equivalent on February 27, 2026. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Atraverse Medical has at least 3 other 510(k) clearances on record.