SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924— 510(k) K010737
Substantially EquivalentMedtronic Cardiac Surgical Products
FDA 510(k) clearance K010737 for SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924, Substantially Equivalent on 2001-04-04. Applicant: Medtronic Cardiac Surgical Products.
Clearance details
- Applicant
- Medtronic Cardiac Surgical Products
- 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.