510(k) K200795 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jul 3, 2020 |
| Received | Mar 26, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2023 | Medtronic Inc. ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor Open, Classified |
MXD | None listed |
| Jan 18, 2022 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) LINQ II Insertable Cardiac Monitor Terminated |
MXD | None listed |
| Jul 14, 2021 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only Open, Classified |
MXD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.