510(k) K212008
K212008 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Reveal LINQ Insertable Cardiac Monitor". The FDA issued a decision of Substantially Equivalent on July 22, 2021. 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
- July 22, 2021
- Date Received
- June 28, 2021
- 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