510(k) K231401 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
| Applicant | Poly Medicure Limited, Faridabad, IN |
| Decision | Substantially Equivalent, Sep 21, 2023 |
| Received | May 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231401
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.