ALBOGRAFT VASCULAR PROSTHESIS— 510(k) K093231

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K093231 for ALBOGRAFT VASCULAR PROSTHESIS, Substantially Equivalent on 2010-01-14. Applicant: LeMaitre Vascular, Inc..

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code MAL
Advisory panel: Cardiovascular
Date received: 2009-10-14
Decision date: 2010-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAL

product code MAL

Death: 4
Total: 4

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.