LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
FDA 510(k) clearance K252593 · decided 2025-09-12
Clearance details
- K-number
- K252593
- Device name
- LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-08-15
- Decision date
- 2025-09-12
- Days to decision
- 28 days
- Clearance type
- Special
- 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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| 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 Corp | 2023-08-19 |
| 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 |
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| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| Axonics Sacral Neuromodulation System (P180046/S113) | Boston Scientific Corporation | 2026-08-07 |
| Axonics Sacral Neuromodulation System (P190006/S113) | Boston Scientific Corporation | 2026-08-07 |
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| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S043) | Boston Scientific Corporation | 2026-08-04 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S009) | Boston Scientific Corporation | 2026-07-30 |
| Axonics Sacral Neuromodulation System (P180046/S110) | Boston Scientific Corporation | 2026-07-24 |
| Axonics Sacral Neuromodulation System (P190006/S110) | Boston Scientific Corporation | 2026-07-24 |
| S-ICD EMBLEM GEN 2 (A209); S-ICD EMBLEM MRI (A219) (P110042/S215) | Boston Scientific Corporation | 2026-07-23 |