MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.— 510(k) K013013
Substantially EquivalentMedtronic Cardiac Surgical Products
FDA 510(k) clearance K013013 for MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR., Substantially Equivalent on 2001-12-04. 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
- Traditional
- Location
- Grand Rapids, MI, 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.