FDA 510(k) Application Details - K153069

Device Classification Name	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter   More FDA Info for this Device
510(K) Number	K153069
Device Name	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Applicant	EDWARDS LIFESCIENCES 1 EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	CHRIS KENNELLY Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	OMZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/2015
Decision Date	01/07/2016
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