Cleared Traditional

K223809 - PrecisionTAVI (v1.1) (FDA 510(k) Clearance)

K223809 · Dasi Simulations · Cardiovascular device
May 2023
Decision
161d
Days
Class 2
Risk

K223809 is an FDA 510(k) clearance for the PrecisionTAVI (v1.1). This device is classified as a Interventional Cardiovascular Implant Simulation Software Device (Class II - Special Controls, product code QQI).

Submitted by Dasi Simulations (Dublin, US). The FDA issued a Cleared decision on May 30, 2023, 161 days after receiving the submission on December 20, 2022.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1405. An Interventional Cardiovascular Implant Simulation Software Device Is A Prescription Device That Provides A Computer Simulation Of An Interventional Cardiovascular Implant Device Inside A Patient’s Cardiovascular Anatomy. It Performs Computational Modeling To Predict The Interaction Of The Interventional Cardiovascular Implant Device With The Patient-specific Anatomical Environment..

Submission Details

510(k) Number K223809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2022
Decision Date May 30, 2023
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QQI - Interventional Cardiovascular Implant Simulation Software Device
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1405
Definition An Interventional Cardiovascular Implant Simulation Software Device Is A Prescription Device That Provides A Computer Simulation Of An Interventional Cardiovascular Implant Device Inside A Patient’s Cardiovascular Anatomy. It Performs Computational Modeling To Predict The Interaction Of The Interventional Cardiovascular Implant Device With The Patient-specific Anatomical Environment.