510(k) K090096

ALL-IN-ONE CONTAINER by Baxter Healthcare Corporation — Product Code KPE

K090096 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "ALL-IN-ONE CONTAINER". The FDA issued a decision of Substantially Equivalent on January 30, 2009. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2009
Date Received
January 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type