510(k) K251007

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) by Circa Scientific, Inc. — Product Code DXF

K251007 is an FDA 510(k) premarket notification submitted by Circa Scientific, Inc. for the device "CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)". The FDA issued a decision of Substantially Equivalent on May 1, 2025. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Circa Scientific, Inc. has at least 7 other 510(k) clearances on record.