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FPB — Filter, Infusion Line Class II

FDA Device Classification

Classification Details

Product Code
FPB
Device Class
Class II
Regulation Number
880.5440
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233277hangzhou qiantang longyue biotechnology coFilter Needle for Single UseMay 10, 2024
K143583merck milliporeCathivex ¿GV filter unitsAugust 11, 2015
K113227baxter healthcareNON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERDecember 8, 2011
K021293arteria medical scienceARTERIA BLOOD FILTERAugust 22, 2002
K993379pallPALL SUPOR AEF FILTERDecember 16, 1999
K974661sims deltec0.2 U BACTERIAL FILTERFebruary 11, 1998
K964283arbor technologiesAUTOPRIMEJanuary 22, 1997
K954331pall biomedical productsPALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)January 9, 1997
K933523mediziv medical products 1987I.V. FILTER SETMay 19, 1995
K941628douglas medical products40 MICRON BLOOD TRANSFUSION FILTERFebruary 16, 1995
K942625medi-dose group1.2 MICRON AIR ELIMINATING FILTEROctober 7, 1994
K943127gelman sciencesPHARMASSURE LARGE VOLUME TRANSFER FILTERSSeptember 29, 1994
K942532medi-dose2 MICRON AIR ELIMINATING FILTERAugust 17, 1994
K941684abbott laboratoriesIVEX-2 EXTENSION SET WITH Y-INJECTION SITEAugust 3, 1994
K942275gelman sciencesVIAL VENT FILTERJuly 26, 1994
K940980b. braun of americaCHARGED SUPOR(R) FILTER EXTENSION SETJuly 14, 1994
K933869baxter healthcareEXTENSION SET WITH 0.22 MICRON 96 HOUR FILTERApril 26, 1994
K940293puritas health care1.2 MICRON FINAL FILTER WITH EXTENSION TUBEMarch 28, 1994
K933294aesculapMIS CLEAN-SET FLUSHING UNIT AND ACCESSORIESFebruary 9, 1994
K935641evans medical0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETSJanuary 28, 1994