The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for 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, Ha.
| Device ID | K171989 |
| 510k 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, Ha |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Ashley Howard |
| Correspondent | Ashley Howard Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-03 |
| Decision Date | 2018-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002572881 | K171989 | 000 |
| 00827002572850 | K171989 | 000 |
| 00827002572898 | K171989 | 000 |