510(k) K172544
K172544 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "IV Fat Emulsion Administration Sets". The FDA issued a decision of Substantially Equivalent on Sep 22, 2017. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has 60 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 22, 2017
- Date Received
- Aug 23, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)