Swang-Ganz IQ pulmonary artery catheter— 510(k) K222117

Substantially Equivalent

Edwards Lifesiences, LLC

FDA 510(k) clearance K222117 for Swang-Ganz IQ pulmonary artery catheter, Substantially Equivalent on 2022-12-09. Applicant: Edwards Lifesiences, LLC.

Clearance details

Applicant: Edwards Lifesiences, LLC
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 2022-07-18
Decision date: 2022-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.