Device |
bone marrow processing device to support hematopoietic reconstitution |
Regulation Description |
Automated blood cell separator. |
Definition |
Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient. |
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 Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | PKG |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
510(k)
|
Regulation Number |
864.9245
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |