EDWARDS TRANSFEMORAL BALLOON CATHETER— 510(k) K140241

Name: FDA 510(k) clearance K140241
Creator: U.S. Food and Drug Administration
Published: 2014-07-03

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K140241 for EDWARDS TRANSFEMORAL BALLOON CATHETER, Substantially Equivalent on 2014-07-03. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code OZT
Device class: Class 2
Regulation: 21 CFR 870.1255
Advisory panel: Cardiovascular
Date received: 2014-01-30
Decision date: 2014-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

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.