V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE

Set, Administration, Intravascular

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for V-link Antimicrobial Luer Activated Device And Extension Sets With V-link Antimicrobial Luer Activated Device.

Pre-market Notification Details

Device IDK081289
510k NumberK081289
Device Name:V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
ContactNanette Hedden
CorrespondentNanette Hedden
BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-05-07
Decision Date2008-08-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412088346 K081289 000
50085412088322 K081289 000
50085412088308 K081289 000

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