510(k) clearances

LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)

Medtronic, Inc. · Cardiovascular

K262735Substantially EquivalentSpecialMXD
Open FDA's page for this record
Third party flag
N
City
Mounds View
Advisory committee description
Cardiovascular
Address 1
8200 Coral Sea St.
Statement or summary
Summary
Product code
MXD
Zip code
55340
Applicant
Medtronic, Inc.
Decision date
2026-08-28
Decision code
SESE
Country code
US
Device name
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
Advisory committee
CV
Contact
Shreya Chenni
K number
K262735
State
MN
Date received
2026-07-31
Review advisory committee
CV
Postal code
55340
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Medical specialty description
Cardiovascular
Regulation number
870.1025
Device class
2
Registration number
9610139, 2124215, 3009380063, 9614453, 1028232, 3015544746, 2182208, 2017865, 3018094310, 3008973940, 9616693, 3004185781
FEI number
3002618605, 2124215, 3002807576, 3009380063, 1028232, 3015544746, 2182208, 2017865, 3018094310, 3002806500, 3008973940, 3004185781
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.