MC3 QuickFlow Dual Lumen Catheter

FDA 510(k) K171610 · Mc3 Incorporated

Substantially Equivalent

510(k) numberK171610

Submission

Device name
MC3 QuickFlow Dual Lumen Catheter
Applicant
Mc3 Incorporated
Dexter, MI, US
Received
June 1, 2017
Decision date
November 16, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PZS – Dual Lumen Ecmo Cannula
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4100
Specialty
Cardiovascular

Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Other 510(k)s with product code PZS

510(k)DeviceApplicantDecision
K232480ProtekDuo Veno-Venous Cannula SetsPZS · Traditional Cardiacassist, Inc.10/06/2023SE
K203409MC3 Crescent Jugular Dual Lumen CatheterPZS · Traditional Mc3, Inc.05/03/2021SE
K180151MC3 Jugular Dual Lumen CatheterPZS · Traditional Mc3 Incorporated07/16/2018SE

More from Mc3 Incorporated

510(k)DeviceDecision
K232767Nautilus VF ECMO OxygenatorBYS · Special 10/04/2023SE
K203409MC3 Crescent Jugular Dual Lumen CatheterPZS · Traditional 05/03/2021SE
K191935Nautilus Smart ECMO ModuleBYS · Traditional 04/09/2020SE
K182914MC3 Vascular Access Kit 21030DRE · Traditional 10/29/2018SE
K180151MC3 Jugular Dual Lumen CatheterPZS · Traditional 07/16/2018SE

Questions and answers

When was MC3 QuickFlow Dual Lumen Catheter cleared by the FDA?

MC3 QuickFlow Dual Lumen Catheter (K171610) received a 510(k) decision of Substantially Equivalent on November 16, 2017, 168 days after the submission was received.

What is the product code of K171610?

The FDA product code is PZS – Dual Lumen Ecmo Cannula, a Class II (moderate risk) device regulated under 21 CFR 870.4100.