SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE— 510(k) K033416
Substantially EquivalentMedtronic Perfusion Systems
FDA 510(k) clearance K033416 for SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE, Substantially Equivalent on 2003-11-05. Applicant: Medtronic Perfusion Systems.
Clearance details
- Applicant
- Medtronic Perfusion Systems
- Product code
- Code DWF
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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.