MXC · Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cardiovascular · 21 CFR 870.2800 · Class 2
Overview
| Product Code | MXC |
|---|---|
| Device Name | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230286 | Assert-IQ Insertable Cardiac Monitor | ABBOTT MEDICAL | May 17, 2023 | SESE |
| K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Aug 13, 2021 | SESE |
| K202876 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Dec 1, 2020 | SESE |
| K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Nov 23, 2020 | SESE |
| K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | Mar 17, 2020 | SESE |
| K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott | Oct 18, 2019 | SESE |
| K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | Apr 10, 2019 | SESE |
| K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott | Mar 29, 2019 | SESE |
| K173232 | myMerlin(TM) Mobile Application Model APP1001 | St Jude Medical | Nov 2, 2017 | SESE |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | Sep 29, 2017 | SESE |
| K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | St. Jude Medical, Inc. | May 28, 2014 | SESE |
| K122161 | SJM CONFIRM | St Jude Medical | Nov 28, 2012 | SESE |
| K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | St. Jude Medical, Cardiac Rhythm Management Divisi | Nov 15, 2012 | SESE |
| K101968 | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A | St Jude Medical | Sep 15, 2010 | SESE |
| K091206 | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL | Transoma Medical | May 18, 2009 | SESE |
| K083828 | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT | Transoma | Feb 11, 2009 | SESE |
| K081365 | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR | St Jude Medical | Aug 15, 2008 | SESE |
| K073147 | SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 | Transoma Medical | Dec 3, 2007 | SESE |
| K063035 | SLEUTH IMPLANTABLE ECG MONITORING SYSTEM | Transnoma Medical, Inc. | Oct 1, 2007 | SESE |
| K011098 | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR | Medtronic Vascular | May 4, 2001 | SESE |
Top Applicants
- Abbott (St. Jude Medical) — 5 clearances
- Medtronic Vascular — 4 clearances
- St Jude Medical — 4 clearances
- Abbott — 2 clearances
- St. Jude Medical, Inc. — 2 clearances
