510(k) K220856
K220856 is an FDA 510(k) premarket notification submitted by Avenir Performance Européenne Medical (Apem) for the device "Vial Adapter Ø13mm". The FDA issued a decision of Substantially Equivalent on Jun 21, 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
- Jun 21, 2022
- Date Received
- Mar 23, 2022
- 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)