FDA applicant
ArteryFlow Technology Co., Ltd.
FDA records 6 decisions for ArteryFlow Technology Co., Ltd. (Hangzhou City, CN) from 2021 to 2023: 6 510(k) clearances. Most are in product codes QHA (X-Ray Angiographic Imaging Based Coronary…) and LLZ (System, Image Processing, Radiological). Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided ArteryFlow Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like ArteryFlow Technology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report