Sat 17 Oct 2026
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| Brand Name | Classification | Manufacturer Name | Status | Details |
|---|---|---|---|---|
| RotaLink™ Advancer Catheter Advancing Device | Class III | Boston Scientific Corporation | Active | Details |
| Rotalink™ Burr Exchangeable Burr Catheter | Class III | Boston Scientific Corporation | Active | Details |
| Rotalink™ Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device | Class III | Boston Scientific Corporation | Active | Details |
| RotaWire™ and wireClip™ Torquer FLOPPY Guidewire and Guidewire Manipulation Device | Class III | Boston Scientific Corporation | Active | Details |
| RotaWire™ and wireClip™ Torquer EXTRA SUPPORT Guidewire and Guidewire Manipulation Device | Class III | Boston Scientific Corporation | Active | Details |
| Rotablator™ Rotational Atherectomy System Console | Class III | Boston Scientific Corporation | Active | Details |
| REBEL™ Monorail™ PtCr Coronary Stent System | Class III | Boston Scientific Corporation | Active | Details |
| PeriVac™ Kit | Class III | Boston Scientific Corporation | Active | Details |
| Coyote™ MONORAIL™ PTA Balloon Dilatation Catheter | Class IIa | Boston Scientific Corporation | Active | Details |
| Coyote™ OVER-THE-WIRE PTA Balloon Dilatation Catheter | Class IIa | Boston Scientific Corporation | Active | Details |
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