Blood Administration Sets

Set, Blood Transfusion

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Blood Administration Sets.

Pre-market Notification Details

Device IDK220558
510k NumberK220558
Device Name:Blood Administration Sets
ClassificationSet, Blood Transfusion
Applicant Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake,  IL  60073
ContactJames L. Vangeisen
CorrespondentMeaghan Bonn
Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake,  IL  60073
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2022-02-28
Decision Date2022-11-17

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