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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Cardiovascular Implant Simulation Software Device
510(k) Number K223809
Device Name PrecisionTAVI (v1.1)
Applicant
Dasi Simulations
5115 Parkcenter Ave.
Suite 205
Dublin,  OH  43017
Applicant Contact Ana Minyayev
Correspondent
Dasi Simulations
5115 Parkcenter Ave.
Suite 205
Dublin,  OH  43017
Correspondent Contact Lakshmi Dasi
Regulation Number870.1405
Classification Product Code
QQI  
Date Received12/20/2022
Decision Date 05/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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