510(k) K193158 · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ACENT Central Venous Catheter
| Applicant | Global Medikit Limited, Dehradun, IN |
| Decision | Substantially Equivalent, Nov 24, 2020 |
| Received | Nov 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193158
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.