Cleared Traditional

Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal

K153074 · Covidien · General Hospital
Jul 2016
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K153074 is an FDA 510(k) clearance for the Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal, a Pump, Infusion, Enteral (Class II — Special Controls, product code LZH), submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on July 6, 2016, 258 days after receiving the submission on October 22, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K153074 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2015
Decision Date July 06, 2016
Days to Decision 258 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZH — Pump, Infusion, Enteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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