FDA 510(k) Application Details - K083814

Device Classification Name	More FDA Info for this Device
510(K) Number	K083814
Device Name	OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
Applicant	CORDIS CORP., A JOHNSON & JOHNSON CO. 7 POWDER HORN DR. WARREN, NJ 07059 US Other 510(k) Applications for this Company
Contact	KAREN WILK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2008
Decision Date	01/13/2009
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