K153074 is an FDA 510(k) clearance for the Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal. 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 July 6, 2016, 258 days after receiving the submission on October 22, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K153074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | LZH — Pump, Infusion, Enteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |