IVX Fluid Transfer Set
FDA 510(k) clearance K212530 · decided 2022-04-24
Clearance details
- K-number
- K212530
- Device name
- IVX Fluid Transfer Set
- Applicant
- Omnicell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-11
- Decision date
- 2022-04-24
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Cranberry, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per Whi recall (Z-1532-2025) | Omnicell, Inc. | 2025-04-04 |