510(k) K141479

KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS by Covidien — Product Code LZH

K141479 is an FDA 510(k) premarket notification submitted by Covidien for the device "KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS". The FDA issued a decision of Substantially Equivalent on December 23, 2014. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Covidien has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2014
Date Received
June 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Enteral
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type