Atlas FDA

LINQ II Insertable Cardiac Monitor

FDA 510(k) clearance K221962 · decided 2022-08-25

Clearance details

K-number
K221962
Device name
LINQ II Insertable Cardiac Monitor
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2022-07-05
Decision date
2022-08-25
Days to decision
51 days
Clearance type
Traditional
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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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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LINQ II™ Insertable Cardiac Monitor (ICM) (K240693)Medtronic, Inc.2024-03-28
LINQ II Insertable Cardiac Monitor (K233562)Medtronic, Inc.2023-12-06
LINQ II™ Insertable Cardiac Monitor (LNQ22) (K233320)Medtronic, Inc.2023-10-31
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
BIOMONITOR IV (K230375)Biotronik, Inc.2023-05-19
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Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System (K223630)Medtronic, Inc.2023-04-05
BIOMONITOR IIIm, BIOMONITOR III (K221856)Biotronik, Inc.2022-07-27

Recalls involving this device

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

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