The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Presep Oligon Oximetry Catheters (16 Cm, W/heparin), (20cm, W/heparin).
| Device ID | K110167 |
| 510k Number | K110167 |
| Device Name: | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-20 |
| Decision Date | 2011-02-18 |
| Summary: | summary |