Cleared Traditional

Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets

K143263 · Covidien · General Hospital
May 2015
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K143263 is an FDA 510(k) clearance for the Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, a Pump, Infusion, Enteral (Class II — Special Controls, product code LZH), submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on May 29, 2015, 197 days after receiving the submission on November 13, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K143263 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2014
Decision Date May 29, 2015
Days to Decision 197 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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