510(k) K142749 ยท DXO Transducer, Pressure, Catheter Tip
TruWave Disposable Pressure Transducer
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 18, 2015 |
| Received | Sep 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142749
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2023 | Edwards Lifesciences, LLC TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX Open, Classified |
DRS | None listed |
| Nov 29, 2023 | Edwards Lifesciences, LLC TruWave with Vamp System Pressure monitoring set,
REF: PXAVMP(3cc)/VAMP 68 in (173cm)
PXAVMP3: x3 (3cc)/VAMP
PXVK0364:(3cc)/VAMP 96in (241cm);
PXVK0853: x3 (3cc)/VAMP 76in (193cm);
PXVK0996:(3cc)/VAM Open, Classified |
DRS | None listed |
| 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 |
| Sep 16, 2015 | Edward Lifesciences, Llc Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requ Terminated |
DXO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.