The following data is part of a premarket notification filed by Medtronic Minimed, Inc. with the FDA for Extended Reservoir.
| Device ID | K210714 |
| 510k Number | K210714 |
| Device Name: | Extended Reservoir |
| Classification | Pump, Infusion, Insulin |
| Applicant | Medtronic MiniMed, Inc. 18000 Devonshire Street Northridge, CA 91325 |
| Contact | Prerna Singh |
| Correspondent | Christina Rowe Medtronic MiniMed, Inc. 18000 Devonshire Street Northridge, CA 91325 |
| Product Code | LZG |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-10 |
| Decision Date | 2022-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000496999 | K210714 | 000 |
| 00763000837259 | K210714 | 000 |
| 20763000837239 | K210714 | 000 |
| 20763000837215 | K210714 | 000 |