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

Name: FDA 510(k) clearance K143454
Creator: U.S. Food and Drug Administration
Published: 2015-08-27

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.. 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: 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 ↗

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, Inc.

view all

K212894 — PhasTIPP2022-03-31
K183513 — XenoSure Dura Biologic Patch2019-06-13
K173323 — AnastoClip GC Closure System2018-03-08
K152833 — Pruitt F3-S Polyurethane Carotid Shunt2016-01-21
K142660 — Antegrade LeMills Valvulotome2014-10-17

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.