FDA 510(k) Application Details - K190267

Device Classification Name	Valvulotome   More FDA Info for this Device
510(K) Number	K190267
Device Name	Valvulotome
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	870.4885   More FDA Info for this Regulation Number
Classification Product Code	MGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2019
Decision Date	10/30/2019
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