K160689 is an FDA 510(k) clearance for the Reveal LINQ. This device is classified as a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II - Special Controls, product code MXD).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on April 22, 2016, 42 days after receiving the submission on March 11, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K160689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2016 |
| Decision Date | April 22, 2016 |
| Days to Decision | 42 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |