FDA 510(k) Application Details - K222297

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K222297
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	Abbott 6035 Stoneridge Drive Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Kim Bondarenko Other 510(k) Applications for this Contact
Regulation Number	870.4350   More FDA Info for this Regulation Number
Classification Product Code	DTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2022
Decision Date	12/01/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review