510(k) K933869

EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER by Baxter Healthcare Corp — Product Code FPB

K933869 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER". The FDA issued a decision of Substantially Equivalent on Apr 26, 1994. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 26, 1994
Date Received
Aug 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type