510(k) K221294

preCARDIA Occlusion System by Abiomed, Inc. — Product Code MJN

K221294 is an FDA 510(k) premarket notification submitted by Abiomed, Inc. for the device "preCARDIA Occlusion System". The FDA issued a decision of SESU on June 30, 2023. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Abiomed, Inc. has at least 10 other 510(k) clearances on record.