18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II— 510(k) K073559

Substantially Equivalent

Edwards Lifesciences Research Medical

FDA 510(k) clearance K073559 for 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II, Substantially Equivalent on 2008-01-31. Applicant: Edwards Lifesciences Research Medical.

Clearance details

Applicant: Edwards Lifesciences Research Medical
Product code: Code DQR
Advisory panel: Cardiovascular
Date received: 2007-12-19
Decision date: 2008-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Midvale, UT, US

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Adverse events under product code DQR

product code DQR

Death: 2
Total: 2

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.