Jot Dx Insertable Cardiac Monitor— 510(k) K212206

Name: FDA 510(k) clearance K212206
Creator: U.S. Food and Drug Administration
Published: 2021-08-13

Substantially Equivalent

Abbott (St. Jude Medical)

FDA 510(k) clearance K212206 for Jot Dx Insertable Cardiac Monitor, Substantially Equivalent on 2021-08-13. Applicant: Abbott (St. Jude Medical). Device class: 2.

Clearance details

Applicant: Abbott (St. Jude Medical)
Product code: Code MXC
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2021-07-15
Decision date: 2021-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MXC

product code MXC

Death: 4
Injury: 758
Malfunction: 5,066
Total: 5,828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.