K182399

Substantially Equivalent

Park Blade Septostomy Catheter

Applicant: Cook Incorporated
Product code: DXF
Advisory panel: Cardiovascular
Date received: 2018-09-04
Decision date: 2019-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Adverse events under product code DXF

product code DXF

Death: 78
Injury: 1,126
Malfunction: 507
Other: 1
Total: 1,712

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.