ArteryFlow Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “ArteryFlow Technology Co., Ltd.” (first 2021, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 206 days. Since 2017 the median was 206 days, against 129 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 239 |
| 2022 | 2 | 217 |
| 2023 | 3 | 127 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name ArteryFlow Technology Co., Ltd. took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| PZO | Software For Visualization Of Vascular Anatomy And Intravascular Devices | 1 | 1 |
Review panels
- Radiology (5)
- Cardiovascular (1)
Most recent ArteryFlow Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231353 | AccuCTP Pro | LLZ | 2023-09-14 | 127 |
| K230303 | AccuFFRangio Plus | QHA | 2023-03-02 | 27 |
| K221711 | AccuICAS | QHA | 2023-02-28 | 260 |
| K220663 | AccuCTP | LLZ | 2022-11-22 | 260 |
| K213838 | AneuGuide | PZO | 2022-06-01 | 174 |
| K210093 | AccuFFRangio | QHA | 2021-09-10 | 239 |
Recalls
openFDA lists no recalls under a recalling firm named ArteryFlow Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under ArteryFlow Technology Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “ArteryFlow Technology Co., Ltd.” (first 2021, latest 2023), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by ArteryFlow Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name ArteryFlow Technology Co., Ltd. is 206 days. Since 2017: 206 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under ArteryFlow Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, 3); LLZ (System, Image Processing, Radiological, 2); PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices, 1).
Next steps
- See all 6 ArteryFlow Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QHA, ArteryFlow Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.