FDA 510(k) Application Details - K190117

Device Classification Name	System, Balloon, Intra-Aortic And Control   More FDA Info for this Device
510(K) Number	K190117
Device Name	System, Balloon, Intra-Aortic And Control
Applicant	Arrow International, Inc. 16 Elizabeth Drive Chelmsford, MA 01824 US Other 510(k) Applications for this Company
Contact	Niyati Boghani Other 510(k) Applications for this Contact
Regulation Number	870.3535   More FDA Info for this Regulation Number
Classification Product Code	DSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2019
Decision Date	06/13/2019
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