EZ-IO Intraosseous Vascular Access System— 510(k) K180395
Substantially EquivalentArrow International, Inc. (Subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K180395 for EZ-IO Intraosseous Vascular Access System, Substantially Equivalent on 2018-11-09. Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.).
Clearance details
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, 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.