Nexus I.V. Fluid Transfer Device
FDA 510(k) K080976 · Nexus Medical, LLC
510(k) numberK080976
Submission
- Device name
- Nexus I.V. Fluid Transfer Device
- Applicant
- Nexus Medical, LLC
Lenexa, KS, US - Received
- April 7, 2008
- Decision date
- November 10, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Nexus I.V. Fluid Transfer Device cleared by the FDA?
Nexus I.V. Fluid Transfer Device (K080976) received a 510(k) decision of Substantially Equivalent on November 10, 2008, 217 days after the submission was received.
What is the product code of K080976?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.