The following data is part of a premarket notification filed by Edwards Lifescience Llc with the FDA for Pediasat Oximetry Catheter, Presep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously Presep Oximetry Catheter).
| Device ID | K172423 |
| 510k Number | K172423 |
| Device Name: | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | Edwards Lifescience LLC One Edwards Way Ivine, CA 92614 |
| Contact | Bedalin T. Lugo Rodriguez |
| Correspondent | Bedalin T. Lugo Rodriguez Edwards Lifescience LLC One Edwards Way Ivine, CA 92614 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2018-02-20 |
| Summary: | summary |