Cardiac Insight, Inc.
Cardiac Insight, Inc. has 0 FDA recalls, 3 inspections, 3 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Feb 7, 2025 · VAI
- Latest 510(k)
- Mar 24, 2017
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 3 | Oct 4, 2026 | Not stated | Current |
| Inspections | 3 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 7, 2025 | Bellevue, WA | Devices | Voluntary Action Indicated (VAI) | 3010342616 |
| Feb 10, 2017 | Bellevue, WA | Devices | Voluntary Action Indicated (VAI) | 3010342616 |
| May 9, 2014 | Bellevue, WA | Devices | No Action Indicated (NAI) | 3010342616 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | Mar 24, 2017 |
| K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | Jul 11, 2015 |
| K130288 | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE | May 29, 2013 |