MXD
- Product code
- MXD
- Device name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1025
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 34
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262735 | 2026-08-28 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | |
| K261074 | 2026-05-01 | Biotronik, Inc. | BIOMONITOR IV (471155) | |
| K253516 | 2025-12-18 | ABBOTT MEDICAL | Assert-IQ (DM5100) | |
| K251221 | 2025-09-17 | Abbott | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ ( | |
| K252593 | 2025-09-12 | Boston Scientific Corporation | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx | |
| K240693 | 2024-03-28 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor (ICM) | |
| K233562 | 2023-12-06 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor | |
| K233320 | 2023-10-31 | Medtronic, Inc. | LINQ II Insertable Cardiac Monitor (LNQ22) | FDA |
Official FDA classification page: MXD
Classification and pathway per current FDA publications. Data from openFDA (CC0).