FDA 510(k) Application Details - DEN160006

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160006
Device Name	everlinQ endoAVF System
Applicant	TVA Medical, Inc. 7000 Bee Cave Rd Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	Noah Bartsch Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2016
Decision Date	06/22/2018
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review