510(k) K193344 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Tri-Ex Extraction Balloon with Multiple Sizing
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Dec 13, 2019 |
| Received | Dec 3, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193344
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.