510(k) K262735
K262735 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2026
- Date Received
- July 31, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type