FDA 510(k) Application Details - K190882

Device Classification Name	More FDA Info for this Device
510(K) Number	K190882
Device Name	XenoSure Biologic Patch
Applicant	LeMaitre Vascular 63 Second Avenue Burlington, MA 01803 US Other 510(k) Applications for this Company
Contact	John N. Bradsher Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2019
Decision Date	02/13/2020
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