MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE— 510(k) K994171
Substantially EquivalentMedtronic Cardiac Surgical Products
FDA 510(k) clearance K994171 for MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE, Substantially Equivalent on 2000-04-27. 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.