| Device Type ID | 2404 |
| Device Name | System, Blood Collection, Vacuum-assisted, Manual |
| Regulation Description | Vacuum-assisted Blood Collection System. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.9125 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KST |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2404 |
| Device | System, Blood Collection, Vacuum-assisted, Manual |
| Product Code | KST |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Vacuum-assisted Blood Collection System. |
| CFR Regulation Number | 864.9125 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 7 |
Fluid Leak | 6 |
Mechanical Problem | 3 |
Leak / Splash | 3 |
Detachment Of Device Component | 2 |
Device Slipped | 1 |
Detachment Of Device Or Device Component | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 24 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hummingbird Med | I | Jul-05-2016 |
| 2 | Hummingbird Med | I | May-20-2016 |