Bone Marrow Processing Device To Support Hematopoietic Reconstitution

Device Code: 2446

Product Code(s): PKG

Definition: Processing Of Bone Marrow Harvested From Human Donors To Support Hematopoietic Reconstitution In A Recipient.

Device Classification Information

Device Type ID2446
Device NameBone Marrow Processing Device To Support Hematopoietic Reconstitution
Physical StateMay Include Centrifuge, Pumps, Valves, Computerized Safety/control Systems, Sterile Single-use Disposable Tubing, And Bags
Technical MethodRelies On A Centrifugal Field And May Include Filtration Methods For Separation Of Harvested Bone Marrow Into Its Cellular And Non-cellular Components.
Target AreaBone Marrow Aspirates Obtained From The Iliac Crest Of Human Donors, Processed And Infused Into The Recipient¿s Circulatory System
Regulation DescriptionAutomated Blood Cell Separator.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(k)
CFR Regulation Number864.9245 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodePKG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2446
DeviceBone Marrow Processing Device To Support Hematopoietic Reconstitution
Product CodePKG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAutomated Blood Cell Separator.
CFR Regulation Number864.9245 [🔎]
TPLC Last Update: 2019-04-02 20:12:20

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