FDA 510(k) Application Details - K121415

Device Classification Name	Stripper, Artery, Intraluminal   More FDA Info for this Device
510(K) Number	K121415
Device Name	Stripper, Artery, Intraluminal
Applicant	LEMAITRE VASCULAR, INC. 63 2ND AVENUE BEDFORD, MA 01803 US Other 510(k) Applications for this Company
Contact	ANDREW HODGKINSON Other 510(k) Applications for this Contact
Regulation Number	870.4875   More FDA Info for this Regulation Number
Classification Product Code	DWX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2012
Decision Date	09/05/2012
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