NEXUS TKO-6P LUER ACTIVATED DEVICE

Set, Administration, Intravascular

NEXUS MEDICAL, LLC

The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Tko-6p Luer Activated Device.

Pre-market Notification Details

Device IDK130416
510k NumberK130416
Device Name:NEXUS TKO-6P LUER ACTIVATED DEVICE
ClassificationSet, Administration, Intravascular
Applicant NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa,  KS  66215
ContactHeather Turner
CorrespondentHeather Turner
NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa,  KS  66215
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-19
Decision Date2013-06-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30892855000868 K130416 000
30892855000509 K130416 000
30815879021046 K130416 000
30815879021466 K130416 000
30815879021602 K130416 000
30815879021619 K130416 000
30815879021626 K130416 000
30815879021633 K130416 000
30815879021640 K130416 000
30892855000608 K130416 000
30892855000615 K130416 000
30892855000622 K130416 000
30892855000851 K130416 000
30892855000790 K130416 000
30892855000783 K130416 000
30892855000776 K130416 000
30892855000769 K130416 000
30892855000752 K130416 000
30892855000745 K130416 000
30892855000721 K130416 000
30815879021817 K130416 000

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