MaxZero Extension Sets With Needle-Free Connector(s)

Set, Administration, Intravascular

Carefusion, Inc.

The following data is part of a premarket notification filed by Carefusion, Inc. with the FDA for Maxzero Extension Sets With Needle-free Connector(s).

Pre-market Notification Details

Device IDK193088
510k NumberK193088
Device Name:MaxZero Extension Sets With Needle-Free Connector(s)
ClassificationSet, Administration, Intravascular
Applicant Carefusion, Inc. 120 S State College Blvd, Suite 100 Brea,  CA  92821
ContactViviana Lai
CorrespondentNesli Karakaya
Carefusion, Inc. 120 S State College Blvd, Suite 100 Brea,  CA  92821
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-06
Decision Date2020-10-23

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