FDA 510(k) Application Details - K162228

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K162228
Device Name	Catheter, Percutaneous
Applicant	AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR 5050 NATHAN LANE PLYMOUTH, MN 55442 US Other 510(k) Applications for this Company
Contact	Mary Johnson Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2016
Decision Date	09/09/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review