Cleared Traditional

NMI DUAL PORT II

K151239 · Navilyst Medical, Inc. · General Hospital
Jun 2016
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K151239 is an FDA 510(k) clearance for the NMI DUAL 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 June 6, 2016, 392 days after receiving the submission on May 11, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K151239 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2015
Decision Date June 06, 2016
Days to Decision 392 days
Submission Type Traditional
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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