Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System— 510(k) K142468

Substantially Equivalent

Cardiac Insight, Inc.

FDA 510(k) clearance K142468 for Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System, Substantially Equivalent on 2015-07-11. Applicant: Cardiac Insight, Inc..

Clearance details

Applicant: Cardiac Insight, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2014-09-03
Decision date: 2015-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, 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.