IVS TUNNELLER DEVICES— 510(k) K073164
Substantially EquivalentCovidien UK Manufacturing, Ltd.
FDA 510(k) clearance K073164 for IVS TUNNELLER DEVICES, Substantially Equivalent on 2008-03-05. Applicant: Covidien UK Manufacturing, Ltd..
Clearance details
- Applicant
- Covidien UK Manufacturing, Ltd.
- Product code
- Code FTL
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Haven, CT, US
Adverse events under product code FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
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.