Cleared Special

PICC Maximal Barrier Nursing Kit

K163452 · Navilyst Medical, Inc. · General Hospital
Feb 2017
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K163452 is an FDA 510(k) clearance for the PICC Maximal Barrier Nursing Kit, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on February 3, 2017, 56 days after receiving the submission on December 9, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K163452 FDA.gov
FDA Decision Cleared SESK
Date Received December 09, 2016
Decision Date February 03, 2017
Days to Decision 56 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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