TruWave Disposable Pressure Transducer
FDA 510(k) clearance K142749 · decided 2015-01-18
Clearance details
- K-number
- K142749
- Device name
- TruWave Disposable Pressure Transducer
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-09-24
- Decision date
- 2015-01-18
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), P recall (Z-0413-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAV recall (Z-0414-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, si recall (Z-2776-2015) | Edward Lifesciences, Llc | 2015-09-16 |