Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name platelet and plasma separator for bone graft handling
510(k) Number BK210591
Tradenames Harvest PRP Separation System, Harvest PRP Separation System with ACDA (30 mL), Harvest PRP Separation System with LP-10, SmartPrep2 System
Device Name Platelet And Plasma Separator For Bone Graft Handling
Original Applicant
Terumo BCT, Inc
10811 w. collins ave.
lakewood,  CO  80215
Regulation Number864.9245
Classification Product Code
ORG  
Date Received05/21/2021
Decision Date 02/11/2022
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-