FDA 510(k) Application Details - K202703

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K202703
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	Vascutek Ltd Newmains Avenue Inchinnan PA4 9RR GB Other 510(k) Applications for this Company
Contact	Chirag Merchant Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	DSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2020
Decision Date	04/06/2021
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