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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-295: AAMI / ANSI BF7:2012, blood transfusion microfilters. (General Plastic Surgery/General Hospital)

Date of Standard: 2012. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
All blood transfusion micro-filters for adults only
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.5440 Microfilter, Blood Transfusion Class 2 CAK
Relevant Guidance:
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on: July 11, 2008
FDA Technical Contact:
 Mary Brooks
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 3453
  Silver Spring MD 20993
  301/796-6078
  email: mary.brooks@fda.hhs.gov
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