PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49— 510(k) K043023

Name: FDA 510(k) clearance K043023
Creator: U.S. Food and Drug Administration
Published: 2004-12-03

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K043023 for PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49, Substantially Equivalent on 2004-12-03. Applicant: LeMaitre Vascular, Inc.. Device class: 2.

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2004-11-03
Decision date: 2004-12-03
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 MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.