510(k) K172544

IV Fat Emulsion Administration Sets by Baxter Healthcare Corporation — Product Code FPA

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)