Atlas FDA

LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US

FDA 510(k) clearance K193473 · decided 2020-06-26

Clearance details

K-number
K193473
Device name
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2019-12-16
Decision date
2020-06-26
Days to decision
193 days
Clearance type
Traditional
Product code
MXD
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St Paul, 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
BIOMONITOR IV (471155) (K261074)Biotronik, Inc.2026-05-01
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LINQ II Insertable Cardiac Monitor (K233562)Medtronic, Inc.2023-12-06
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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
LINQ II Insertable Cardiac Monitor (K221962)Medtronic, Inc.2022-08-25

Recalls involving this device

No recalls on record reference this clearance.

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