FDA 510(k) Application Details - K151610

Device Classification Name	Transducer, Pressure, Catheter Tip   More FDA Info for this Device
510(K) Number	K151610
Device Name	Transducer, Pressure, Catheter Tip
Applicant	BOSTON SCIENTIFIC CORPORATION 47215 LAKEVIEW BOULEVARD FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	JAMES KLEINEDLER 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	06/15/2015
Decision Date	10/06/2015
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