Definition: Preparation Of Autologous Platelet Rich Plasma From A Small Sample Of Peripheral Blood For Clinical Use
Device Type ID | 2511 |
Device Name | Peripheral Blood Processing Device For Clinical Use |
Physical State | May Include Centrifuge, Filters, Tubes, Syringes, Needles, Other Disposables And Anticoagulant |
Technical Method | Uses Centrifugal And/or Filtration Methods To Separate The Whole Blood Into Components, After Which The Platelet Rich Plasma Is Withdrawn |
Target Area | Blood Drawn From Peripheral Veins, PRP Applied Clinically |
Review Panel | Hematology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | Enforcement Discretion |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | PZV |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |