Device Atlas

PrecisionTAVI (v1.1)

Q: What is the product code of K223809?

The FDA product code is QQI – Interventional Cardiovascular Implant Simulation Software Device, a Class II (moderate risk) device regulated under 21 CFR 870.1405.

FDA 510(k) K223809 · Dasi Simulations

Substantially Equivalent

510(k) numberK223809

Submission

Device name: PrecisionTAVI (v1.1)
Applicant: Dasi Simulations
Dublin, OH, US
Received: December 20, 2022
Decision date: May 30, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QQI – Interventional Cardiovascular Implant Simulation Software Device
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1405
Specialty: Cardiovascular

An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patients cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

Other 510(k)s with product code QQI

510(k)	Device	Applicant	Decision
K250635	FEops HEARTguide Simulation ApplicationQQI · Traditional	Feops NV	11/25/2025SE
K214066	FEops HEARTguideQQI · Traditional	Feops NV	02/25/2022SE

More from Feops NV

510(k)	Device	Decision
K231324	DASI Dimensions (V1.0)QIH · Traditional	01/08/2024SE

Questions and answers

When was PrecisionTAVI (v1.1) cleared by the FDA?

PrecisionTAVI (v1.1) (K223809) received a 510(k) decision of Substantially Equivalent on May 30, 2023, 161 days after the submission was received.

What is the product code of K223809?

The FDA product code is QQI – Interventional Cardiovascular Implant Simulation Software Device, a Class II (moderate risk) device regulated under 21 CFR 870.1405.