Vyntus / SentrySuite Product Line
FDA 510(k) clearance K150810 · decided 2015-08-14
Clearance details
- K-number
- K150810
- Device name
- Vyntus / SentrySuite Product Line
- Applicant
- Carefusion Germany 234 GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-03-26
- Decision date
- 2015-08-14
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- BZC
- Device class
- 2
- Regulation number
- 868.1880
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hoechberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinT recall (Z-1730-2024) | Vyaire Medical, Inc. | 2024-05-08 |