FDA 510(k) Application Details - K121083

Device Classification Name	More FDA Info for this Device
510(K) Number	K121083
Device Name	TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
Applicant	LOMA VISTA MEDICAL 1307 SOUTH MARY AVE, STE 280 SUNNYVALE, CA 94087 US Other 510(k) Applications for this Company
Contact	TIFFINI DIAGE 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	04/10/2012
Decision Date	10/11/2012
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