FDA 510(k) Application Details - K191246

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K191246
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	Carol Middleton 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	05/09/2019
Decision Date	02/28/2020
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