MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES— 510(k) K033264

Substantially Equivalent

Medtronic Perfusion Systems

FDA 510(k) clearance K033264 for MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES, Substantially Equivalent on 2003-10-31. Applicant: Medtronic Perfusion Systems.

Clearance details

Applicant: Medtronic Perfusion Systems
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2003-10-09
Decision date: 2003-10-31
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.