DeviceClearance

EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA— 510(k) K113411

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K113411 for EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA, Substantially Equivalent on 2012-06-11. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant
Edwards Lifesciences, LLC
Product code
Code DWF
Device class
Class 2
Regulation
21 CFR 870.4210
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Draper, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DWF

product code DWF
Death
106
Injury
386
Malfunction
2,323
Total
2,815

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K113411

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113411.

Data sourced from openFDA. This site is unofficial and independent of the FDA.