VESSEL GUARDIAN— 510(k) K102136

Name: FDA 510(k) clearance K102136
Creator: U.S. Food and Drug Administration
Published: 2010-09-27

Substantially Equivalent

Lexion Medical, LLC

FDA 510(k) clearance K102136 for VESSEL GUARDIAN, Substantially Equivalent on 2010-09-27. Applicant: Lexion Medical, LLC. Device class: 2.

Clearance details

Applicant: Lexion Medical, LLC
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2010-07-29
Decision date: 2010-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.