Wilson-Cook Medical, Inc. · Class II · Cleared Mar 20, 2018
| K-number | K171989 |
| Device name | Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter |
| Applicant | Wilson-Cook Medical, Inc. |
| Product code | ODD |
| Device class | Class II |
| Decision date | Mar 20, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
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