Allen, TX, US · 6 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | Class II | General Hospital | 4 | 2024-12-18 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | Class II | Cardiovascular | 2 | 2020-11-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-07-14 | Class II | Ongoing | Z-0197-2024 | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets … | — | For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous… |
| 2022-12-23 | Class II | Ongoing | Z-1100-2023 | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 | — | Delivery Sets may have tubing that could become detached that could result in patient infection. |
| 2022-12-23 | Class II | Ongoing | Z-1100-2023 | Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2 | — | Delivery Sets may have tubing that could become detached that could result in patient infection. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-12-18 | K241058 | Lyka® PORT Needle Free Access Device (4170Y) | FPA | Class II | General Hospital |
| 2022-06-05 | K213846 | Q2 Blood Administration Sets | FPA | Class II | General Hospital |
| 2022-06-02 | K213588 | Q2 IV Administration Sets | FPA | Class II | General Hospital |
| 2021-01-21 | K202672 | Precision Delivery Infusion Set | FPA | Class II | General Hospital |
| 2020-11-20 | K201984 | MPS 3 ND Myocardial Protection System | DTR | Class II | Cardiovascular |
| 2020-06-19 | K200438 | MPS 3 Myocardial Protection System | DTR | Class II | Cardiovascular |