FDA applicant
Shanghai MicroPort Medical (Group) Co., Ltd.
FDA records 3 decisions for Shanghai MicroPort Medical (Group) Co., Ltd. (Shanghai, CN) from 2015 to 2026: 3 510(k) clearances. All are in product code LOX (Catheters, Transluminal Coronary Angioplasty…). Its devices cite 3 predicates, 0 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 Shanghai MicroPort Medical (Group) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Shanghai MicroPort Medical (Group)…’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