510(k) K210660 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Stone Retrieval Balloon Catheter
| Applicant | Anrei Medical (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Apr 27, 2021 |
| Received | Mar 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210660
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.