Swan-Ganz Catheters— 510(k) K193466

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K193466 for Swan-Ganz Catheters, Substantially Equivalent on 2020-02-16. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 2019-12-16
Decision date: 2020-02-16
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.