INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003— 510(k) K071307
Substantially EquivalentInviro Medical Devices, Inc.
FDA 510(k) clearance K071307 for INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003, Substantially Equivalent on 2008-02-12. Applicant: Inviro Medical Devices, Inc..
Clearance details
- Applicant
- Inviro Medical Devices, Inc.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Duluth, GA, US
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.