Cleared Special

NMI Port, NMI Port II

K153228 · Navilyst Medical, Inc. · General Hospital
Dec 2015
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K153228 is an FDA 510(k) clearance for the NMI Port, NMI Port II, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on December 4, 2015, 28 days after receiving the submission on November 6, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K153228 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2015
Decision Date December 04, 2015
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

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