510(k) K252419

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

K252419 is an FDA 510(k) premarket notification submitted by Atraverse Medical, Inc. for the device "HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)". The FDA issued a decision of Substantially Equivalent on August 27, 2025. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Atraverse Medical, Inc. has at least 3 other 510(k) clearances on record.