FDA Product Code
FDA Product Code MXC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2800
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230286 | Assert-IQ Insertable Cardiac Monitor | ABBOTT MEDICAL | 2023-05-17 | Traditional | PDF ↗ |
| K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2021-08-13 | Special | PDF ↗ |
| K202876 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020-12-01 | Special | PDF ↗ |
| K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020-11-23 | Traditional | PDF ↗ |
| K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | 2020-03-17 | Traditional | PDF ↗ |
| K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019-10-18 | Special | PDF ↗ |
| K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2019-04-10 | Traditional | PDF ↗ |
| K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019-03-29 | Traditional | PDF ↗ |
| K173232 | myMerlin(TM) Mobile Application Model APP1001 | St Jude Medical | 2017-11-02 | Special | PDF ↗ |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | 2017-09-29 | Traditional | PDF ↗ |
| K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | St. Jude Medical, Inc. | 2014-05-28 | Traditional | PDF ↗ |
| K122161 | SJM CONFIRM | St Jude Medical | 2012-11-28 | Traditional | PDF ↗ |
| K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-11-15 | Traditional | PDF ↗ |
| K101968 | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A | St Jude Medical | 2010-09-15 | Special | PDF ↗ |
| K091206 | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL | Transoma Medical | 2009-05-18 | Special | PDF ↗ |
| K083828 | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT | Transoma | 2009-02-11 | Special | PDF ↗ |
| K081365 | SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR | St Jude Medical | 2008-08-15 | Traditional | PDF ↗ |
| K073147 | SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 | Transoma Medical | 2007-12-03 | Special | PDF ↗ |
| K063035 | SLEUTH IMPLANTABLE ECG MONITORING SYSTEM | Transnoma Medical, Inc. | 2007-10-01 | Traditional | PDF ↗ |
| K011098 | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR | Medtronic Vascular | 2001-05-04 | Special | PDF ↗ |
| K003667 | REVEAL PLUS INSERTABLE LOOP RECORDER | Medtronic Vascular | 2001-02-14 | Traditional | PDF ↗ |
| K994331 | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR | Medtronic Vascular | 2000-01-21 | Special | PDF ↗ |
| K972242 | REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM | Medtronic Vascular | 1998-01-16 | Traditional | PDF ↗ |
Product code MXC · Class II · Cardiovascular. Data: openFDA.