Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software— 510(k) K162503

Name: FDA 510(k) clearance K162503
Creator: U.S. Food and Drug Administration
Published: 2017-03-24

Substantially Equivalent

Cardiac Insight, Inc.

FDA 510(k) clearance K162503 for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software, Substantially Equivalent on 2017-03-24. Applicant: Cardiac Insight, Inc.. Device class: 2.

Clearance details

Applicant: Cardiac Insight, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2016-09-07
Decision date: 2017-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.