Houston, TX, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QFJ | Intravascular Bleed Monitor | Class II | Cardiovascular | 1 | 2023-05-25 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-08-10 | Class II | Ongoing | Z-1684-2022 | Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F) | — | Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to i… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-05-25 | K230273 | Saranas Early Bird Bleed Monitoring System | QFJ | Class II | Cardiovascular |