510(k) K171996 ยท DXO Transducer, Pressure, Catheter Tip
TruWave Disposable Pressure Transducer
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 23, 2017 |
| Received | Jul 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171996
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.