510(k) K190001 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Supercath 5
| Applicant | Togo Medikit Co., Ltd., Hyuga City, JP |
| Decision | Substantially Equivalent, Sep 20, 2019 |
| Received | Jan 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190001
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.