RETROFLEX DILATOR KIT— 510(k) K093554

Name: FDA 510(k) clearance K093554
Creator: U.S. Food and Drug Administration
Published: 2010-04-13

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K093554 for RETROFLEX DILATOR KIT, Substantially Equivalent on 2010-04-13. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DRE
Device class: Class 2
Regulation: 21 CFR 870.1310
Advisory panel: Cardiovascular
Date received: 2009-11-17
Decision date: 2010-04-13
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 DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.