FDA 510(k) Application Details - K132474

Device Classification Name	Transducer, Pressure, Catheter Tip   More FDA Info for this Device
510(K) Number	K132474
Device Name	Transducer, Pressure, Catheter Tip
Applicant	ACIST MEDICAL SYSTEMS 7905 FULLER ROAD EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	MATTHEW STEPANEK Other 510(k) Applications for this Contact
Regulation Number	870.2870   More FDA Info for this Regulation Number
Classification Product Code	DXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2013
Decision Date	01/30/2014
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