K250283

Substantially Equivalent

RAP Femoral Venous Cannulae

Applicant: LivaNova USA, Inc.
Product code: DWF
Advisory panel: Cardiovascular
Date received: 2025-01-31
Decision date: 2025-07-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Arvada, CO, 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.