5403 Betsy Ross Drive, Santa Clara, United States, 95054
Showing 1–20 of 31 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| INTRAVASCULAR LITHOTRIPSY CONNECTOR CABLE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| INTRAVASCULAR LITHOTRIPSY GENERATOR AND CONNECTOR CABLE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Neovasc Reducer™ System | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| SHOCKWAVE C2 AERO CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Catheter + Cable Sleeve | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter + Cable Sleeve | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter + Cable Sleeve | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Shockwave CS Guide Catheter | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| SHOCKWAVE E8 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| SHOCKWAVE JAVELIN PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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