LIFESPAN EPTFE VASCULAR GRAFT— 510(k) K130016

Name: FDA 510(k) clearance K130016
Creator: U.S. Food and Drug Administration
Published: 2013-02-05

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K130016 for LIFESPAN EPTFE VASCULAR GRAFT, Substantially Equivalent on 2013-02-05. Applicant: LeMaitre Vascular, Inc.. Device class: 2.

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 2013-01-01
Decision date: 2013-02-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.