CORE RESISTANT HUBER INFUSION SETS

Set, Administration, Intravascular

ICU MEDICAL, INC.

The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Core Resistant Huber Infusion Sets.

Pre-market Notification Details

Device IDK972712
510k NumberK972712
Device Name:CORE RESISTANT HUBER INFUSION SETS
ClassificationSet, Administration, Intravascular
Applicant ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente,  CA  92673
ContactArlene Dutchik
CorrespondentArlene Dutchik
ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente,  CA  92673
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-21
Decision Date1997-10-01
Summary:summary

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