ANSI AAMI BF7:2012 Blood transfusion microfilters |
Recognition Date | 2013-08-06 |
Recognition List | 031 |
Recognition Number | 6-295 |
Extent | Complete standard |
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STG | General Plastic Surgery/General Hospital |
FDA Tech | Mary Brooks FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6078 Mary.Brooks@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard describes safety and performance requirements for disposable microfilters used for the removal of
microaggregates from blood or blood products during transfusion.
Regulation Number | Device Name | Device Class | Product Code |
§880.5440 | Microfilter, Blood Transfusion | Class 2 | CAK |
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008 |