Submission Details
| 510(k) Number | K231328 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 08, 2023 |
| Decision Date | August 19, 2023 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
LUX-Dx II (M302); LUX-Dx II+ (M312)
Aug 2023
Decision
103d
Days
Class 2
Risk
About This 510(k) Submission
K231328 is an FDA 510(k) clearance for the LUX-Dx II (M302); LUX-Dx II+ (M312), a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II — Special Controls, product code MXD), submitted by Boston Scientific Corp (Alternate Contact, US). The FDA issued a Cleared decision on August 19, 2023, 103 days after receiving the submission on May 8, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
Manufacturer
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