FDA 510(k) Application Details - K120349

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K120349
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	ULTRASONIX MEDICAL CORPATION 130-4311 VIKING WAY RICHOND, BC V6V 2K9 CA Other 510(k) Applications for this Company
Contact	CHAS YU Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/06/2012
Decision Date	04/09/2012
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	Y
Expedited Review