Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K100739
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 · Edwards Lifesciences, LLC · decided 2010-12-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VOLUMEVIEW | VLVFC520 | Edwards Lifesciences LLC | KRB | 00690103183917 |
| 1-FEMORAL CATHETER KIT (5F, 20 CM), SINGLE PACK | VLVFC520 | Edwards Lifesciences LLC | KRB | 00690103190397 |
| VOLUMEVIEW | VLVCVT5 | Edwards Lifesciences LLC | KRB | 00690103190427 |
| VolumeView | VLV8R416 | Edwards Lifesciences LLC | KRB | 00690103187052 |
| VolumeView | VLVFC416 | Edwards Lifesciences LLC | KRB | 00690103185485 |
| VolumeView | VLV6R520 | Edwards Lifesciences LLC | KRB | 00690103187007 |
| VOLUMEVIEW | VLVFC5205 | Edwards Lifesciences LLC | KRB | 00690103183924 |
| VOLUMEVIEW | VLVCVT5 | Edwards Lifesciences LLC | KRB | 00690103183900 |
| VolumeView | VLV6R416 | Edwards Lifesciences LLC | KRB | 00690103187045 |
| VOLUMEVIEW | VLV8R5205 | Edwards Lifesciences LLC | KRB | 00690103187021 |
| VolumeView | VLV8R520 | Edwards Lifesciences LLC | KRB | 00690103187014 |
| VOLUMEVIEW | VLV6R5205 | Edwards Lifesciences LLC | KRB | 00690103187038 |
| VOLUMEVIEW | VLV8R4165 | Edwards Lifesciences LLC | KRB | 00690103187069 |
| VOLUMEVIEW | VLV6R4165 | Edwards Lifesciences LLC | KRB | 00690103187076 |
| VOLUMEVIEW | VLV8R5 | Edwards Lifesciences LLC | DRS KRB | 07460691950481 |