SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011— 510(k) K034058

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K034058 for SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011, Substantially Equivalent on 2004-01-29. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2003-12-30
Decision date: 2004-01-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.