FDA 510(k) Application Details - K103250

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K103250
Device Name	Catheter, Percutaneous
Applicant	ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. SYLMAR, CA 91342 US Other 510(k) Applications for this Company
Contact	COLLEEN CANAN 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	11/03/2010
Decision Date	01/19/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review