The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Fusion Quattro Extraction Balloon.
| Device ID | K200247 |
| 510k Number | K200247 |
| Device Name: | Fusion Quattro Extraction Balloon |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Tiffanny A Thomas |
| Correspondent | Tiffanny A Thomas Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-31 |
| Decision Date | 2020-02-27 |