K160645 is an FDA 510(k) clearance for the PreSep Oligon Oximetry Catheter. This device is classified as a Catheter, Oximeter, Fiber-optic (Class II - Special Controls, product code DQE).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 16, 2016, 101 days after receiving the submission on March 7, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1230.
| 510(k) Number | K160645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2016 |
| Decision Date | June 16, 2016 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQE — Catheter, Oximeter, Fiber-optic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1230 |