510(k) K230553 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Apr 26, 2023 |
| Received | Feb 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230553
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.