| Device Type ID | 2388 |
| Device Name | Set, Transfer (blood/plasma) |
| Regulation Description | Transfer Set. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9875 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KSB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2388 |
| Device | Set, Transfer (blood/plasma) |
| Product Code | KSB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transfer Set. |
| CFR Regulation Number | 864.9875 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CHARTER MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHARTER MEDICAL, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KAWASUMI LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Mechanical Problem | 26 |
Dent In Material | 5 |
Separation Failure | 5 |
Adverse Event Without Identified Device Or Use Problem | 2 |
No Apparent Adverse Event | 1 |
Inadequate User Interface | 1 |
| Total Device Problems | 40 |