FDA 510(k) Application Details - K212894

Device Classification Name	Stripper, Vein, External   More FDA Info for this Device
510(K) Number	K212894
Device Name	Stripper, Vein, External
Applicant	LeMaitre Vascular Inc. 63 Second Ave Burlington, MA 01803 US Other 510(k) Applications for this Company
Contact	Anurag Gadgil Other 510(k) Applications for this Contact
Regulation Number	870.4885   More FDA Info for this Regulation Number
Classification Product Code	DWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2021
Decision Date	03/31/2022
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