FDA 510(k) Application Details - K203307

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K203307
Device Name	Clamp, Vascular
Applicant	Vascular Graft Solutions, Ltd. 24 Raoul Wallenberg St Tel-Aviv 6971921 IL Other 510(k) Applications for this Company
Contact	Orit Yarden Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	DXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2020
Decision Date	02/17/2021
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