FDA 510(k) Application Details - K234118

Device Classification Name	More FDA Info for this Device
510(K) Number	K234118
Device Name	CentriMagÖ Acute Circulatory Support System
Applicant	Abbott Medical 6035 Stoneridge Drive Pleasanton Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Bendre Ketaki Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2023
Decision Date	01/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review