510(k) K183413 ยท DXO Transducer, Pressure, Catheter Tip
TruWave Disposable Pressure Transducer
| Applicant | Edwards Lifeciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 1, 2019 |
| Received | Dec 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183413
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.