K972242 is an FDA 510(k) clearance for the REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM. This device is classified as a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II - Special Controls, product code MXC).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 16, 1998, 214 days after receiving the submission on June 16, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K972242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | June 16, 1997 |
| Decision Date | January 16, 1998 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |