The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Presep Oligon Oximetry Catheter.
| Device ID | K160645 |
| 510k Number | K160645 |
| Device Name: | PreSep Oligon Oximetry Catheter |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | EDWARDS LIFESCIENCES, LLC 1 EDWARDS WAY Irvine, CA 92614 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell EDWARDS LIFESCIENCES, LLC 1 EDWARDS WAY Irvine, 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 | 2016-03-07 |
| Decision Date | 2016-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103197204 | K160645 | 000 |
| 00690103197181 | K160645 | 000 |
| 00690103197174 | K160645 | 000 |
| 00690103195309 | K160645 | 000 |