This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K252508 | Intri26 Introducer Sheath | 2025-12-17 |
| US | K253323 | Protrieve Sheath | 2025-10-29 |
| US | K250421 | InThrill Thrombectomy System | 2025-05-12 |
| BR | 82968079001 | Cateter de Trombectomia VenaCore | Class II |
| BR | 80102519154 | Sistema de Trombectomia ClotTriever | Class II |
| BR | 82968079002 | Sistema de Trombectomia Artix | Class II |