MXC — Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) Class II
FDA product code MXC covers "Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)", a Class II medical device regulated under 21 CFR 870.2800. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MXC
- Device Class
- Class II
- Regulation Number
- 870.2800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230286 | abbott medical | Assert-IQ Insertable Cardiac Monitor | May 17, 2023 |
| K212206 | abbott (st. jude medical) | Jot Dx Insertable Cardiac Monitor | August 13, 2021 |
| K202876 | abbott (st. jude medical) | Confirm Rx Insertable Cardiac Monitor | December 1, 2020 |
| K202888 | abbott (st. jude medical) | Confirm Rx Insertable Cardiac Monitor | November 23, 2020 |
| K193310 | abbott (st. jude medical) | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | March 17, 2020 |
| K192593 | abbott | Confirm Rx Insertable Cardiac Monitor | October 18, 2019 |
| K190295 | abbott (st. jude medical) | Confirm Rx Insertable Cardiac Monitor | April 10, 2019 |
| K182981 | abbott | Confirm Rx Insertable Cardiac Monitor | March 29, 2019 |
| K173232 | st jude medical | myMerlin(TM) Mobile Application Model APP1001 | November 2, 2017 |
| K163407 | st. jude medical | Confirm Rx Insertable Cardiac Monitor (ICM) System | September 29, 2017 |
| K133481 | st. jude medical | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | May 28, 2014 |
| K122161 | st jude medical | SJM CONFIRM | November 28, 2012 |
| K122090 | st. jude medical, cardiac rhythm management divisi | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | November 15, 2012 |
| K101968 | st jude medical | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A | September 15, 2010 |
| K091206 | transoma medical | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAG | May 18, 2009 |
| K083828 | transoma | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL | February 11, 2009 |
| K081365 | st jude medical | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT A | August 15, 2008 |
| K073147 | transoma medical | SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 | December 3, 2007 |
| K063035 | transnoma medical | SLEUTH IMPLANTABLE ECG MONITORING SYSTEM | October 1, 2007 |
| K011098 | medtronic vascular | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND | May 4, 2001 |