FDA applicant
Sunwei Tech Co., Ltd.
FDA records 1 decision for Sunwei Tech Co., Ltd. (Houston, TX) in 2006: 1 510(k) clearance. All are in product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). 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 Sunwei Tech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sunwei Tech Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sunwei Tech 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