Arisure Neutral Valve
FDA 510(k) K120799 · Yukon Medical, LLC
510(k) numberK120799
Submission
- Device name
- Arisure Neutral Valve
- Applicant
- Yukon Medical, LLC
Durham, NC, US - Received
- March 16, 2012
- Decision date
- March 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | 03/21/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | 12/06/2024SE |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD)ONB · Traditional | 03/02/2021SE |
| K172884 | Arisure Closed Vial AdapterLHI · Traditional | 10/03/2017SE |
| K172631 | Arisure Dry SpikeLHI · Traditional | 09/29/2017SE |
| K171101 | Closed Male LuerFPA · Traditional | 06/02/2017SE |
| K151963 | SmartSite Vented Vial Access DeviceLHI · Traditional | 07/31/2015SE |
| K132863 | Smartsite VialshieldLHI · Traditional | 10/04/2013SE |
| K122265 | Vialok Single Vial Access Device VentedLHI · Traditional | 08/14/2012SE |
| K121182 | Vialok Non-VentedLHI · Traditional | 05/03/2012SE |
Questions and answers
When was Arisure Neutral Valve cleared by the FDA?
Arisure Neutral Valve (K120799) received a 510(k) decision of Substantially Equivalent on March 30, 2012, 14 days after the submission was received.
What is the product code of K120799?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.