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 |