FDA 510(k) Application Details - K152613

Device Classification Name	More FDA Info for this Device
510(K) Number	K152613
Device Name	True Flow Valvuloplasty Perfusion Catheter
Applicant	C. R. BARD, INC. 1625 WEST 3RD STREET TEMPE, AZ 85281 US Other 510(k) Applications for this Company
Contact	AARON CONOVALOFF Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2015
Decision Date	01/19/2016
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