Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter— 510(k) K221528

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K221528 for Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter, Substantially Equivalent on 2022-08-22. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 2022-05-26
Decision date: 2022-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.