510(k) K232852

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable by Cross Vascular, Inc. — Product Code DXF

K232852 is an FDA 510(k) premarket notification submitted by Cross Vascular, Inc. for the device "Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable". The FDA issued a decision of Substantially Equivalent on October 12, 2023. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Cross Vascular, Inc. has at least 1 other 510(k) clearance on record.