510(k) K200173 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Stone Retrieval Balloon
| Applicant | Hangzhou AGS MedTech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, May 1, 2020 |
| Received | Jan 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200173
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.