FDA 510(k) Application Details - K090163

Device Classification Name	Stylet, Catheter   More FDA Info for this Device
510(K) Number	K090163
Device Name	Stylet, Catheter
Applicant	ST. JUDE MEDICAL 15900 VALLEY VIEW COURT SYLMAR,, CA 91342 US Other 510(k) Applications for this Company
Contact	GEENA GEORGE Other 510(k) Applications for this Contact
Regulation Number	870.1380   More FDA Info for this Regulation Number
Classification Product Code	DRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2009
Decision Date	04/01/2009
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