K053609 is an FDA 510(k) clearance for the PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR. 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 February 28, 2006, 63 days after receiving the submission on December 27, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1230.
| 510(k) Number | K053609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2005 |
| Decision Date | February 28, 2006 |
| Days to Decision | 63 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 |