Device |
peripheral blood processing device for wound management |
Regulation Description |
Automated blood cell separator. |
Definition |
Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management. |
Physical State |
May include centrifuge and sterile single-use tubes and disposables |
Technical Method |
Uses centrifugal methods to separate whole blood into components, after which the platelet rich plasma gel is withdrawn |
Target Area |
Blood drawn from peripheral veins, PRP gel topically applied to exuding cutaneous wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically-debrided wounds |
Regulation Medical Specialty |
Hematology |
Review Panel |
Hematology |
Product Code | PMQ |
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 |