510(k) K932301

FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER by Baxter Healthcare Corp — Product Code FPB

K932301 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER". The FDA issued a decision of Substantially Equivalent on Nov 10, 1993. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 10, 1993
Date Received
May 12, 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
510(k)

Source: FDA 510(k) database entry for K932301. Report a data issue: hello@regdatalab.com.