MC3 Jugular Dual Lumen Catheter— 510(k) K180151

Name: FDA 510(k) clearance K180151
Creator: U.S. Food and Drug Administration
Published: 2018-07-16

Substantially Equivalent

Mc3 Incorporated

FDA 510(k) clearance K180151 for MC3 Jugular Dual Lumen Catheter, Substantially Equivalent on 2018-07-16. Applicant: Mc3 Incorporated. Device class: 2.

Clearance details

Applicant: Mc3 Incorporated
Product code: Code PZS
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2018-01-19
Decision date: 2018-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dexter, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PZS

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K232480 — ProtekDuo Veno-Venous Cannula Sets2023-10-06
K203409 — MC3 Crescent Jugular Dual Lumen Catheter2021-05-03
K171610 — MC3 QuickFlow Dual Lumen Catheter2017-11-16

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K191935 — Nautilus Smart ECMO Module2020-04-09
K182914 — MC3 Vascular Access Kit 210302018-10-29

Adverse events under product code PZS

product code PZS

Death: 17
Total: 17

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.