FDA 510(k) Application Details - K223809

Device Classification Name	More FDA Info for this Device
510(K) Number	K223809
Device Name	PrecisionTAVI (v1.1)
Applicant	DASI Simulations 5115 Parkcenter Ave Suite 205 Dublin, OH 43017 US Other 510(k) Applications for this Company
Contact	Ana Minyayev Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2022
Decision Date	05/30/2023
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