510(k) K230553
- Device
- LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
- Applicant
- Medtronic, Inc.
- 510(k) number
- K230553
- Product code
- MXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-26
- Date received
- 2023-02-28
- Regulation
- 870.1025
- Classification name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Kerry Luyster
- Address
- 8200 Coral Sea St. N.E Mounds View MN US 55112 55112
FDA Registration Numbers
- 3009380063
- 2124215
- 2182208
- 2017865
- 3018094310
- 3015544746
- 1028232
- 9616693
- 3004185781
- 9614453
- 9610139
- 3008973940
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00763000754914 | CareLink SmartSync™ LINQ II™ Insertable Cardiac Monitor (ICM) Application | MEDTRONIC, INC. | 2024-04-25 |
Other 510(k) Records For Product Code MXD
| 510(k) | Device | Applicant | Decision date |
|---|
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | 2026-05-01 |
| K253516 | Assert-IQ (DM5100) | ABBOTT MEDICAL | 2025-12-18 |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | 2025-09-17 |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | 2025-09-12 |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | 2024-03-28 |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2023-12-06 |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | 2023-10-31 |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023-08-19 |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | 2023-05-19 |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | 2023-04-05 |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2022-08-25 |
| K221856 | BIOMONITOR IIIm, BIOMONITOR III | Biotronik, Inc. | 2022-07-27 |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2021-07-22 |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | 2021-06-11 |
| K211304 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2021-05-28 |