510(k) K172884
K172884 is an FDA 510(k) premarket notification submitted by Yukon Medical for the device "Arisure Closed Vial Adapter". The FDA issued a decision of Substantially Equivalent on October 3, 2017. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Yukon Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2017
- Date Received
- September 21, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type