Intravascular Administration 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 Intravascular Administration Sets.

Pre-market Notification Details

Device IDK203609
510k NumberK203609
Device Name:Intravascular Administration Sets
ClassificationSet, Administration, Intravascular
Applicant Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake,  IL  60073
ContactJeffrey E. Thompson
CorrespondentJeffrey E. Thompson
Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake,  IL  60073
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-09-30

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