ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106— 510(k) K024069

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K024069 for ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106, Substantially Equivalent on 2003-01-08. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2002-12-10
Decision date: 2003-01-08
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.