Pruitt F3-S Carotid Shunt— 510(k) K143454

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K143454 for Pruitt F3-S Carotid Shunt, Substantially Equivalent on 2015-08-27. Applicant: LeMaitre Vascular, Inc..

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2014-12-03
Decision date: 2015-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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.