LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
FDA 510(k) K193473 · Boston Scientific Corporation
510(k) numberK193473
Submission
- 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
St Paul, MN, US - Received
- December 16, 2019
- Decision date
- June 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code MXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)MXD · Special | Medtronic, Inc. | 08/28/2026SE |
| K261074 | Biomonitor IV (471155)MXD · Special | Biotronik, Inc. | 05/01/2026SE |
| K253516 | Assert-IQ (DM5100)MXD · Special | Abbott Medical | 12/18/2025SE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD · Traditional | Abbott | 09/17/2025SE |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXD · Special | Boston Scientific Corporation | 09/12/2025SE |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM)MXD · Special | Medtronic, Inc. | 03/28/2024SE |
| K233562 | LINQ II Insertable Cardiac MonitorMXD · Special | Medtronic, Inc. | 12/06/2023SE |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22)MXD · Special | Medtronic, Inc. | 10/31/2023SE |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312)MXD · Traditional | Boston Scientific Corp | 08/19/2023SE |
| K230375 | Biomonitor IVMXD · Traditional | Biotronik, Inc. | 05/19/2023SE |
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Questions and answers
When was LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US cleared by the FDA?
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US (K193473) received a 510(k) decision of Substantially Equivalent on June 26, 2020, 193 days after the submission was received.
What is the product code of K193473?
The FDA product code is MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), a Class II (moderate risk) device regulated under 21 CFR 870.1025.