The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Presep And Pediasat Oximetry Catheters And Vigileo Arterial Pressure Cardiac Output/oximetry Monitor.
| Device ID | K053609 |
| 510k Number | K053609 |
| Device Name: | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Diane Peterson |
| Correspondent | Diane Peterson EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DQE |
| Subsequent Product Code | DRE |
| Subsequent Product Code | DXG |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-12-27 |
| Decision Date | 2006-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103197594 | K053609 | 000 |
| 00690103176810 | K053609 | 000 |
| 00690103197433 | K053609 | 000 |
| 00690103197440 | K053609 | 000 |
| 00690103197457 | K053609 | 000 |
| 00690103197488 | K053609 | 000 |
| 00690103197518 | K053609 | 000 |
| 00690103197525 | K053609 | 000 |
| 00690103197532 | K053609 | 000 |
| 00690103197549 | K053609 | 000 |
| 00690103197556 | K053609 | 000 |
| 00690103197563 | K053609 | 000 |
| 00690103197570 | K053609 | 000 |
| 00690103197587 | K053609 | 000 |
| 00690103163384 | K053609 | 000 |