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

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..

Clearance details

Applicant: Cardiac Insight, Inc.
Product code: Code DSH
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 ↗

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.