510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QEKClass II

Angiographic Coronary Vascular Physiologic Simulation Software

21 CFR 870.1415 / Cardiovascular
FDA source (opens on fda.gov)

QEK is the FDA product code for Angiographic Coronary Vascular Physiologic Simulation Software, a class II device type, regulated under 21 CFR 870.1415. FDA's definition for this code reads: "An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QEK
Device name
Angiographic Coronary Vascular Physiologic Simulation Software
FDA definition
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Regulation
21 CFR 870.1415
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QEK

By decision year
2 clearances under product code QEK with a decision year between 2018 and 2019, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QEK by decision year
YearClearances
20181
20191

Applicants with the most clearances

Product code QEK
Applicants holding the most 510(k) clearances under product code QEK
ApplicantClearances
Cathworks Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code