510(k) K160235 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ViaValve Safety I.V. Catheter
| Applicant | Smiths Medical Asd, Inc., Southington CT, US |
| Decision | Substantially Equivalent, Jun 30, 2016 |
| Received | Feb 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160235
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2018 | Smiths Medical ASD Inc. Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10
The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopa Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.