MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)— 510(k) K241849
Substantially EquivalentImaxeon Pty, Ltd.
FDA 510(k) clearance K241849 for MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2), Substantially Equivalent on 2024-11-05. Applicant: Imaxeon Pty, Ltd..
Clearance details
- Applicant
- Imaxeon Pty, Ltd.
- Product code
- Code IZQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rydalmere, AU
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.