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

Coronary Vascular Physiologic Simulation Software

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

PJA is the FDA product code for Coronary Vascular Physiologic Simulation Software, a class II device type, regulated under 21 CFR 870.1415. FDA's definition for this code reads: "A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PJA
Device name
Coronary Vascular Physiologic Simulation Software
FDA definition
A 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
9
Ingested recalls
0

Clearances, product code PJA

By decision year
9 clearances under product code PJA with a decision year between 2014 and 2025, 2016 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PJA by decision year
YearClearances
20141
20162
20181
20191
20211
20222
20251

Applicants with the most clearances

Product code PJA
Applicants holding the most 510(k) clearances under product code PJA
ApplicantClearances
Heartflow, Inc.8
Keyamed Na, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code