FDA 510(k) Application Details - K150836

Device Classification Name	More FDA Info for this Device
510(K) Number	K150836
Device Name	OUTBACK Elite Re-Entry Catheter
Applicant	CORDIS CORPORATION, A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PARKWAY FREMONT, CA 94555 US Other 510(k) Applications for this Company
Contact	MICHELLE RAGOZZINO RODGERS 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	03/30/2015
Decision Date	04/29/2015
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