510(k) K212525
K212525 is an FDA 510(k) premarket notification submitted by Advcare Medical for the device "Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices". The FDA issued a decision of Substantially Equivalent on Aug 19, 2022. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2022
- Date Received
- Aug 11, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)