FDA 510(k) Application Details - K201642

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K201642
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	Chalice Medical Ltd Manton Wood Enterprise Park Worksop S80 2RS GB Other 510(k) Applications for this Company
Contact	Stephen Horan 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	06/17/2020
Decision Date	09/18/2020
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