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

Name: FDA 510(k) clearance K182916
Creator: U.S. Food and Drug Administration
Published: 2018-11-16

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. Device class: 2.

Clearance details

Applicant: Lemaitre Vascular
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
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 ↗

Recent devices under product code MJN

view all

K243795 — pREBOA-PRO Catheter2025-09-05
K251358 — Bridge Plus Occlusion Balloon (590-002)2025-06-24
K221294 — preCARDIA Occlusion System2023-06-30
K214060 — LANDMARK REBOA Catheter2022-09-19
K211610 — Fogarty Occlusion Catheter2022-02-14

More clearances from Lemaitre Vascular

view all

K190882 — XenoSure Biologic Patch2020-02-13
K190267 — EZE SIT Valvulotome2019-10-30

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.