510(k) K161962 ยท KRA Catheter, Continuous Flush
VAMP Venous/Arterial Blood Management Protection System
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 28, 2016 |
| Received | Jul 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2021 | Edwards Lifesciences, LLC Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507 Terminated |
DXO | None listed |
| May 26, 2021 | Edwards Lifesciences, LLC Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489 Terminated |
DXO | None listed |
| May 26, 2021 | Edwards Lifesciences, LLC Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within t Terminated |
DXO | None listed |
| May 26, 2021 | Edwards Lifesciences, LLC Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520 Terminated |
DXO | None listed |
| May 26, 2021 | Edwards Lifesciences, LLC Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782 Terminated |
DXO | None listed |
| May 26, 2021 | Edwards Lifesciences, LLC Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370 Terminated |
DXO | None listed |
| May 26, 2021 | Edwards Lifesciences, LLC Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547 Terminated |
DXO | None listed |
| May 26, 2021 | Edwards Lifesciences, LLC Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746 Terminated |
DXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.