510(k) K201415
K201415 is an FDA 510(k) premarket notification submitted by West Pharmaceutical Services Az, Inc. for the device "Vial2Bag Advanced 20mm Admixture Device". The FDA issued a decision of Substantially Equivalent on October 21, 2020. 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
- October 21, 2020
- Date Received
- May 29, 2020
- 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