510(k) K170029 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
| Applicant | International Biophysics Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Dec 15, 2017 |
| Received | Jan 4, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2019 | OriGen Biomedical, Inc. 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.