Cleared Traditional

NIPRO SAFE TOUCH HUBER INFUSION SET

K113470 · Nipro Medical Corporation · General Hospital
Oct 2012
Decision
330d
Days
Class 2
Risk

About This 510(k) Submission

K113470 is an FDA 510(k) clearance for the NIPRO SAFE TOUCH HUBER INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on October 17, 2012, 330 days after receiving the submission on November 22, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K113470 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2011
Decision Date October 17, 2012
Days to Decision 330 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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