Atlas FDA

LINQ II Insertable Cardiac Monitor

FDA 510(k) clearance K211304 · decided 2021-05-28

Clearance details

K-number
K211304
Device name
LINQ II Insertable Cardiac Monitor
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2021-04-29
Decision date
2021-05-28
Days to decision
29 days
Clearance type
Special
Product code
MXD
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor recall (Z-0421-2024)Medtronic Inc.2023-12-01

PMA approvals by this applicant

RecordFirmDate
SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455)Medtronic, Inc.2025-12-22
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527)Medtronic, Inc.2025-12-22
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574)Medtronic, Inc.2025-12-19
SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08