The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Tri-ex Extraction Balloon With Multiple Sizing.
| Device ID | K193344 |
| 510k Number | K193344 |
| Device Name: | Tri-Ex Extraction Balloon With Multiple Sizing |
| 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 | Theresa De Prat |
| Correspondent | Theresa De Prat Wilson-Cook Medical Inc. 4900 Bethania Station Road Winstom-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 | 2019-12-03 |
| Decision Date | 2019-12-13 |