FDA 510(k) Application Details - K112797

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K112797
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	CORDIS CORP. 430 ROUTE 22 EAST BRIDGEWATER, NJ 08807 US Other 510(k) Applications for this Company
Contact	DANNA MARSHALL Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	LIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2011
Decision Date	05/04/2012
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