VAMP Plus Venous/Arterial Blood Management Protection System
FDA 510(k) clearance K181684 · decided 2018-11-08
Clearance details
- K-number
- K181684
- Device name
- VAMP Plus Venous/Arterial Blood Management Protection System
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-06-26
- Decision date
- 2018-11-08
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- 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 with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAV recall (Z-0414-2024) | Edwards Lifesciences, LLC | 2023-11-29 |