Protek Solo 24 Fr Venous Cannula Set— 510(k) K162214

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K162214 for Protek Solo 24 Fr Venous Cannula Set, Substantially Equivalent on 2016-11-30. Applicant: Cardiacassist, Inc..

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2016-08-08
Decision date: 2016-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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.