The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Volumeview System, Models Vlv520ft6r, Vlv520ft8r, Vlv520ft6r5.
| Device ID | K100739 |
| 510k Number | K100739 |
| Device Name: | VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 |
| Classification | Probe, Thermodilution |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Patricia Milbank |
| Correspondent | Patricia Milbank EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-16 |
| Decision Date | 2010-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103190427 | K100739 | 000 |
| 00690103183900 | K100739 | 000 |
| 00690103183917 | K100739 | 000 |
| 00690103183924 | K100739 | 000 |
| 00690103185485 | K100739 | 000 |
| 00690103187007 | K100739 | 000 |
| 00690103187014 | K100739 | 000 |
| 00690103187021 | K100739 | 000 |
| 00690103187038 | K100739 | 000 |
| 00690103187045 | K100739 | 000 |
| 00690103187052 | K100739 | 000 |
| 00690103187069 | K100739 | 000 |
| 00690103187076 | K100739 | 000 |
| 00690103190397 | K100739 | 000 |
| 07460691950481 | K100739 | 000 |