FDA 510(k) Application Details - K200438

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K200438
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 US Other 510(k) Applications for this Company
Contact	Tosan Onosode Other 510(k) Applications for this Contact
Regulation Number	870.4240   More FDA Info for this Regulation Number
Classification Product Code	DTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2020
Decision Date	06/19/2020
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