The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Linq Ii Insertable Cardiac Monitor.
| Device ID | K221962 |
| 510k Number | K221962 |
| Device Name: | LINQ II Insertable Cardiac Monitor |
| Classification | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE MS-MVS11 Mounds View, MN 55112 |
| Contact | Dianna L. Johannson |
| Correspondent | Dianna L. Johannson Medtronic, Inc. 8200 Coral Sea Street NE MS-MVS11 Mounds View, MN 55112 |
| Product Code | MXD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-05 |
| Decision Date | 2022-08-25 |