510(k) K193440

ER-REBOA PLUS Catheter by Prytime Medical Devices, Inc. — Product Code MJN

K193440 is an FDA 510(k) premarket notification submitted by Prytime Medical Devices, Inc. for the device "ER-REBOA PLUS Catheter". The FDA issued a decision of Substantially Equivalent on January 9, 2020. 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.