510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K223809Substantially Equivalent

PrecisionTAVI (v1.1)

Dasi Simulations, Dublin OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223809 is the FDA 510(k) clearance record for PrecisionTAVI (v1.1), a class II device, cleared for Dasi Simulations on under FDA product code QQI (Interventional Cardiovascular Implant Simulation Software Device). FDA's definition for product code QQI reads: "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...". FDA records list 2 510(k) clearances for Dasi Simulations, from to . As of , FDA records show no recalls naming K223809.

Clearance record

Decision date
Received
(161 days to decision)
Product code
QQI Interventional Cardiovascular Implant Simulation Software Device
Regulation
21 CFR 870.1405
Device class
Class II
Review panel
Cardiovascular
Applicant
Dasi Simulations 5115 Parkcenter Ave., Dublin OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQI

Trailing 12 months
1 clearance under product code QQI in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QQI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260