510(k) K180302 · MQF Catheter, Assisted Reproduction
Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 24, 2018 |
| Received | Feb 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180302
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.