1625 West 3rd Street, Tempe, United States, 85281
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Lutonix 014 Drug Coated Balloon PTA Catheter | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| LUTONIX 014 DRUG COATED PTA DILATATION CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| LUTONIX 018 DRUG COATED BALLOON PTA CATHETER | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Lutonix 018 Drug Coated Balloon PTA Catheter Model 9014 | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Lutonix Drug Coated Balloon PTA Catheter | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| LUTONIXTM 014 Drug Coated Balloon PTA Catheter Model 9005 | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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