LINQ II Insertable Cardiac Monitor (ICM)
FDA 510(k) K240693 · Medtronic, Inc.
510(k) numberK240693
Submission
- Device name
- LINQ II Insertable Cardiac Monitor (ICM)
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- March 13, 2024
- Decision date
- March 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code MXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)MXD · Special | Medtronic, Inc. | 08/28/2026SE |
| K261074 | Biomonitor IV (471155)MXD · Special | Biotronik, Inc. | 05/01/2026SE |
| K253516 | Assert-IQ (DM5100)MXD · Special | Abbott Medical | 12/18/2025SE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD · Traditional | Abbott | 09/17/2025SE |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXD · Special | Boston Scientific Corporation | 09/12/2025SE |
| K233562 | LINQ II Insertable Cardiac MonitorMXD · Special | Medtronic, Inc. | 12/06/2023SE |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22)MXD · Special | Medtronic, Inc. | 10/31/2023SE |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312)MXD · Traditional | Boston Scientific Corp | 08/19/2023SE |
| K230375 | Biomonitor IVMXD · Traditional | Biotronik, Inc. | 05/19/2023SE |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMXD · Traditional | Medtronic, Inc. | 04/26/2023SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)MXD · Special | 08/28/2026SE |
| K262005 | Affera Integrated Mapping SystemDQK · Special | 08/21/2026SE |
| K261335 | VitalFlow Set with Balance BiosurfaceQJZ · Traditional | 07/31/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | 06/24/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | 05/28/2026SE |
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | 04/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | 02/19/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | 01/20/2026SE |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | 01/16/2026SE |
| K251831 | Bio-Medicus Life Support Catheter and IntroducerQHW · Traditional | 01/15/2026SE |
Questions and answers
When was LINQ II Insertable Cardiac Monitor (ICM) cleared by the FDA?
LINQ II Insertable Cardiac Monitor (ICM) (K240693) received a 510(k) decision of Substantially Equivalent on March 28, 2024, 15 days after the submission was received.
What is the product code of K240693?
The FDA product code is MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), a Class II (moderate risk) device regulated under 21 CFR 870.1025.