SLEUTH IMPLANTABLE ECG MONITORING SYSTEM— 510(k) K063035

Substantially Equivalent

Transnoma Medical, Inc.

FDA 510(k) clearance K063035 for SLEUTH IMPLANTABLE ECG MONITORING SYSTEM, Substantially Equivalent on 2007-10-01. Applicant: Transnoma Medical, Inc..

Clearance details

Applicant: Transnoma Medical, Inc.
Product code: Code MXC
Advisory panel: Cardiovascular
Date received: 2006-09-29
Decision date: 2007-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

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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.