Edwards eSheath Optima introducer set— 510(k) K244046

Substantially Equivalent

Edwards Lifesciences

FDA 510(k) clearance K244046 for Edwards eSheath Optima introducer set, Substantially Equivalent on 2025-03-27. Applicant: Edwards Lifesciences.

Clearance details

Applicant: Edwards Lifesciences
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2024-12-30
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.