Cleared Traditional

LifeCare PCA Infusion System

K143612 · Hospira, Inc. · General Hospital
Apr 2016
Decision
476d
Days
Class 2
Risk

About This 510(k) Submission

K143612 is an FDA 510(k) clearance for the LifeCare PCA Infusion System, a Pump, Infusion, Pca (Class II — Special Controls, product code MEA), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on April 8, 2016, 476 days after receiving the submission on December 19, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K143612 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2014
Decision Date April 08, 2016
Days to Decision 476 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MEA — Pump, Infusion, Pca
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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