Solution Administration Sets With 0.2 Micron Filter

Set, Administration, Intravascular

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Solution Administration Sets With 0.2 Micron Filter.

Pre-market Notification Details

Device IDK153158
510k NumberK153158
Device Name:Solution Administration Sets With 0.2 Micron Filter
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORPORATION 32650 N WILSON ROAD Round Lake,  IL  60073
ContactGary Chumbimune
CorrespondentGary Chumbimune
BAXTER HEALTHCARE CORPORATION 32650 N WILSON ROAD Round Lake,  IL  60073
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-02
Decision Date2015-12-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412565755 K153158 000
50085412002281 K153158 000
50085412003998 K153158 000
50085412013713 K153158 000
50085412046322 K153158 000
50085412046339 K153158 000
50085412048494 K153158 000
50085412048517 K153158 000
50085412065323 K153158 000
50085412071669 K153158 000
50085412079672 K153158 000
50085412080951 K153158 000
50085412002274 K153158 000

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