510(k) K243795

pREBOA-PRO Catheter by Prytime Medical Devices, Inc. — Product Code MJN

K243795 is an FDA 510(k) premarket notification submitted by Prytime Medical Devices, Inc. for the device "pREBOA-PRO Catheter". The FDA issued a decision of Substantially Equivalent on September 5, 2025. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Prytime Medical Devices, Inc. has at least 4 other 510(k) clearances on record.