510(k) K190149
K190149 is an FDA 510(k) premarket notification submitted by Avenir Performance Europeenne Medical (Apem) for the device "Vial Adapter Ø20 mm". The FDA issued a decision of Substantially Equivalent on Oct 15, 2019. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Avenir Performance Europeenne Medical (Apem) has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 15, 2019
- Date Received
- Jan 29, 2019
- 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)