EDWARDS EMBOL-X INTRODUCER SHEATH— 510(k) K123714

Name: FDA 510(k) clearance K123714
Creator: U.S. Food and Drug Administration
Published: 2013-07-24

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K123714 for EDWARDS EMBOL-X INTRODUCER SHEATH, Substantially Equivalent on 2013-07-24. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2012-12-04
Decision date: 2013-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

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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.