K210714 is an FDA 510(k) clearance for the Extended Reservoir. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on April 6, 2022, 392 days after receiving the submission on March 10, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K210714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2021 |
| Decision Date | April 06, 2022 |
| Days to Decision | 392 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |