K991170

Substantially Equivalent

RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014

Applicant: Edwards Lifesciences Research Medical
Product code: DWF
Advisory panel: Cardiovascular
Date received: 1999-04-07
Decision date: 1999-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midvale, UT, US

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.