FDA 510(k) Application Details - K131592

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K131592
Device Name	Catheter, Percutaneous
Applicant	ST. JUDE MEDICAL, INC. 5050 NATHAN LANE NORTH PLYMOUTH, MN 55442 US Other 510(k) Applications for this Company
Contact	BLAIR SCHWARTZ 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	06/03/2013
Decision Date	01/31/2014
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