Cleared Traditional

NEXUS TKO-6P LUER ACTIVATED DEVICE

K130416 · Nexus Medical, LLC · General Hospital
Jun 2013
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K130416 is an FDA 510(k) clearance for the NEXUS TKO-6P LUER ACTIVATED DEVICE, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Nexus Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on June 12, 2013, 113 days after receiving the submission on February 19, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K130416 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2013
Decision Date June 12, 2013
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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