Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr— 510(k) K182916

Substantially Equivalent

Lemaitre Vascular

FDA 510(k) clearance K182916 for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr, Substantially Equivalent on 2018-11-16. Applicant: Lemaitre Vascular.

Clearance details

Applicant: Lemaitre Vascular
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2018-10-18
Decision date: 2018-11-16
Decision: Substantially Equivalent
Clearance type: Special
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.