FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER

Filter, Infusion Line

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Fenwal(r) 40/150 Micron Dual Screen Filter.

Pre-market Notification Details

Device IDK932301
510k NumberK932301
Device Name:FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER
ClassificationFilter, Infusion Line
Applicant BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
ContactEllen Snyder
CorrespondentEllen Snyder
BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
Product CodeFPB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-12
Decision Date1993-11-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412065293 K932301 000
50085412031199 K932301 000

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