ALBOSURE POLYESTER VASCULAR PATCH— 510(k) K101740

Name: FDA 510(k) clearance K101740
Creator: U.S. Food and Drug Administration
Published: 2010-09-20

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K101740 for ALBOSURE POLYESTER VASCULAR PATCH, Substantially Equivalent on 2010-09-20. Applicant: LeMaitre Vascular, Inc.. Device class: 2.

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2010-06-21
Decision date: 2010-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.