510(k) K172423 ยท DQE Catheter, Oximeter, Fiber-Optic
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
| Applicant | Edwards Lifescience, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 20, 2018 |
| Received | Aug 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172423
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | Edwards Lifesciences, LLC Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 Terminated |
DQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.