K112225

Substantially Equivalent

SORIN CENTRIFUGAL PUMP 5 (CP5)

Applicant: Sorin Group Deutschland GmbH
Product code: DWA
Advisory panel: Cardiovascular
Date received: 2011-08-03
Decision date: 2011-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.