510(k) K213868 ยท DQX Wire, Guide, Catheter
ASAHI Gladius Mongo18 PV ES
| Applicant | Asahi Intecc Co., Ltd., Seto, JP |
| Decision | Substantially Equivalent, Sep 6, 2022 |
| Received | Dec 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213868
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.