Definition: Processing Of Bone Marrow Harvested From Human Donors To Support Hematopoietic Reconstitution In A Recipient.
| Device Type ID | 2446 |
| Device Name | Bone Marrow Processing Device To Support Hematopoietic Reconstitution |
| Physical State | May Include Centrifuge, Pumps, Valves, Computerized Safety/control Systems, Sterile Single-use Disposable Tubing, And Bags |
| Technical Method | Relies On A Centrifugal Field And May Include Filtration Methods For Separation Of Harvested Bone Marrow Into Its Cellular And Non-cellular Components. |
| Target Area | Bone Marrow Aspirates Obtained From The Iliac Crest Of Human Donors, Processed And Infused Into The Recipient¿s Circulatory System |
| Regulation Description | Automated Blood Cell Separator. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9245 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PKG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |