Intellifuse Administration And Intellifuse Blood Administration Sets

Set, Administration, Intravascular

Smiths Medical ASD, Inc.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Intellifuse Administration And Intellifuse Blood Administration Sets.

Pre-market Notification Details

Device IDK192375
510k NumberK192375
Device Name:Intellifuse Administration And Intellifuse Blood Administration Sets
ClassificationSet, Administration, Intravascular
Applicant Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis,  MN  55442
ContactWendy Hills
CorrespondentDanielle Besal
MRC/X, LLC 6075 Poplar Avenue, Suite 500 Memphis,  TN  38119
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-30
Decision Date2020-09-18

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