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510(k) K203409

MC3 Crescent Jugular Dual Lumen Catheter by Mc3, Inc. — Product Code PZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2021
Date Received
November 19, 2020
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, Inc.

  • K232767 — Nautilus VF ECMO Oxygenator (October 4, 2023)

Other clearances for product code PZS

  • K232480 — ProtekDuo Veno-Venous Cannula Sets (October 6, 2023)
  • K180151 — MC3 Jugular Dual Lumen Catheter (July 16, 2018)
  • K171610 — MC3 QuickFlow Dual Lumen Catheter (November 16, 2017)