FDA 510(k) Application Details - K140438

Device Classification Name	More FDA Info for this Device
510(K) Number	K140438
Device Name	MICRO GUIDE CATHETER ELITE
Applicant	CORDIS CORP., A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PKWY. FREMONT, CA 94555 US Other 510(k) Applications for this Company
Contact	Michelle Ragozzine 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	02/21/2014
Decision Date	11/14/2014
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	N
Expedited Review