FDA 510(k) Application Details - K132777

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K132777
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	EV3 INC 3033 Campus Drive Plymouth, MN 55441 US Other 510(k) Applications for this Company
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	09/05/2013
Decision Date	09/26/2013
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	Y
Expedited Review