K062265
Substantially EquivalentCT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
- Applicant
- Swiss Medical Care S.A.
- Product code
- IZQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Flemington, NJ, US
Adverse events under product code IZQ
product code IZQ- Death
- 7
- Total
- 7
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.