Home / 510(k) Clearances / K171610

510(k) K171610

MC3 QuickFlow Dual Lumen Catheter by Mc3 Incorporated — Product Code PZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2017
Date Received
June 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dual Lumen Ecmo Cannula
Device Class
Class II
Regulation Number
870.4100
Review Panel
CV
Submission Type

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 clearances by Mc3 Incorporated

  • K191935 — Nautilus Smart ECMO Module (April 9, 2020)
  • K182914 — MC3 Vascular Access Kit 21030 (October 29, 2018)
  • K180151 — MC3 Jugular Dual Lumen Catheter (July 16, 2018)

Other clearances for product code PZS

  • K232480 — ProtekDuo Veno-Venous Cannula Sets (October 6, 2023)
  • K203409 — MC3 Crescent Jugular Dual Lumen Catheter (May 3, 2021)
  • K180151 — MC3 Jugular Dual Lumen Catheter (July 16, 2018)