freeflex+ Transfer Adapter
FDA 510(k) K212445 · Fresenius Kabi AG
510(k) numberK212445
Submission
- Device name
- freeflex+ Transfer Adapter
- Applicant
- Fresenius Kabi AG
Bad Homburg, DE - Received
- August 5, 2021
- Decision date
- June 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 freeflex+ Transfer Adapter cleared by the FDA?
freeflex+ Transfer Adapter (K212445) received a 510(k) decision of Substantially Equivalent on June 1, 2022, 300 days after the submission was received.
What is the product code of K212445?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.