K011098 is an FDA 510(k) clearance for the REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR. 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 May 4, 2001, 23 days after receiving the submission on April 11, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K011098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2001 |
| Decision Date | May 04, 2001 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |