FDA 510(k) Application Details - K150667

Device Classification Name	More FDA Info for this Device
510(K) Number	K150667
Device Name	True Dilatation Balloon Valvuloplasty Catheter
Applicant	C.R. Bard, Inc. 1625 W. Third St. 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	03/16/2015
Decision Date	06/17/2015
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