CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS

Set, Administration, Intravascular

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Clearlink Luer Activated Valve, Clearlink System Non-dehp Catheter Extension Sets.

Pre-market Notification Details

Device IDK112893
510k NumberK112893
Device Name:CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. Mcgaw Park,  IL  60085
ContactNanette Hedden
CorrespondentNanette Hedden
BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN RD. Mcgaw Park,  IL  60085
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-03
Decision Date2011-10-18
Summary:summary

NIH GUDID Devices

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