Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff— 510(k) K193077
Substantially EquivalentCovidien
FDA 510(k) clearance K193077 for Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff, Substantially Equivalent on 2020-06-01. Applicant: Covidien.
Clearance details
- Applicant
- Covidien
- Product code
- Code JOH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Adverse events under product code JOH
product code JOH- Death
- 42
- Injury
- 1,344
- Malfunction
- 5,608
- Other
- 1
- Total
- 6,995
Source: openFDA MAUDE database, through . 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.