SARNS SOFT-FLOW AORTIC CANNULA— 510(k) K132451

Substantially Equivalent

Terumo Cardiovascular Systems Corp.

FDA 510(k) clearance K132451 for SARNS SOFT-FLOW AORTIC CANNULA, Substantially Equivalent on 2014-02-18. Applicant: Terumo Cardiovascular Systems Corp..

Clearance details

Applicant: Terumo Cardiovascular Systems Corp.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2013-08-06
Decision date: 2014-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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.