Recognized standard
CN27:2021
FDA recognition 6-481 · ANSI · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-481 |
|---|---|
| Designation | CN27:2021 |
| Title | General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications |
| Standards developer | American National Standards Institute |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: