FDA 510(k)

PrecisionTAVI (v1.1)

K-Number: K223809 · 2023-05-30

Decision Date2023-05-30

Product CodeQQI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PrecisionTAVI (v1.1) is the device name listed in this FDA 510(k) record. The listed applicant is Dasi Simulations. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K223809. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrecisionTAVI (v1.1)?

PrecisionTAVI (v1.1) is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Dasi Simulations. The 510(k) number is K223809.

When did PrecisionTAVI (v1.1) receive FDA 510(k) clearance?

PrecisionTAVI (v1.1) received FDA 510(k) clearance on 2023-05-30, under 510(k) number K223809.

Who is the listed applicant for PrecisionTAVI (v1.1)?

The FDA 510(k) record lists Dasi Simulations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PrecisionTAVI (v1.1)?

The FDA product code for PrecisionTAVI (v1.1) is QQI.

Other records listing Dasi Simulations as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231324DASI Dimensions (V1.0)

Related Devices (Code: QQI)

K250635FEops HEARTguide Simulation ApplicationFeops NV K214066FEops HEARTguideFeops NV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.