EV1000 Clinical Platform NI, EV1000 Clinical Platform— 510(k) K192058

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K192058 for EV1000 Clinical Platform NI, EV1000 Clinical Platform, Substantially Equivalent on 2019-08-30. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2019-08-01
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.