510(k) K210602

AortaSTAT Occlusion Device by Renalpro Medical, Inc. — Product Code MJN

K210602 is an FDA 510(k) premarket notification submitted by Renalpro Medical, Inc. for the device "AortaSTAT Occlusion Device". The FDA issued a decision of Substantially Equivalent on July 9, 2021. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450.