K141479 is an FDA 510(k) clearance for the KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS. This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on December 23, 2014, 202 days after receiving the submission on June 4, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K141479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2014 |
| Decision Date | December 23, 2014 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZH — Pump, Infusion, Enteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |