Cleared Traditional

All Safe Huber Safety Infusion Set

K142590 · Nexus Medical, LLC · General Hospital
Jan 2015
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K142590 is an FDA 510(k) clearance for the All Safe Huber Safety Infusion Set, 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 January 16, 2015, 123 days after receiving the submission on September 15, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K142590 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2014
Decision Date January 16, 2015
Days to Decision 123 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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