Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-119: AAMI / ANSI BF7:1989/ (R) 2011, Blood transfusion micro-filters. (General Plastic Surgery/General Hospital)
Date of Standard: 1989. |
| Addresses of Standards 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: |
|
| 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: |
| Anthony D. Watson |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2516 |
| Silver Spring MD 20993 |
| 301/796-6296 |
| Email: anthony.watson@fda.hhs.gov |
|
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