FDA 510(k) Application Details - K172305

Device Classification Name	System, Balloon, Intra-Aortic And Control   More FDA Info for this Device
510(K) Number	K172305
Device Name	System, Balloon, Intra-Aortic And Control
Applicant	Datascope Corp. 1300 MacArthur Blvd. Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	Helder A. Sousa 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	07/31/2017
Decision Date	10/12/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review