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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 6-481
Standard
ANSI AAMI  CN27:2021
General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
Scope/Abstract
This standard covers Luer activated valves (LAVs) for intravascular applications, which open and permit access to the fluid conduit when a male Luer connector is inserted.

This standard applies only to the valve end of LAVs.

This standard applies to LAVs as stand-alone devices or as components of a medical device.

This standard does not address valves that are opened by a female Luer connector.

This standard does not address the connection features of the non-valve end of LAVs and/or other integrated features (e.g., stopcock handles) (Figure 1).
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5440 Stopcock, I.V. Set Class 2 FMG
§880.5440 Set, Administration, Intravascular Class 2 FPA
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 11, 2008.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 David Wolloscheck
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  David.Wolloscheck@fda.hhs.gov
 Sreya Tarafdar
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  Sreya.Tarafdar@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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