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510(k) K191935

Nautilus Smart ECMO Module by Mc3 Incorporated — Product Code BYS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2020
Date Received
July 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Long Term Support Greater Than 6 Hours
Device Class
Class II
Regulation Number
870.4100
Review Panel
CV
Submission Type

Other clearances by Mc3 Incorporated

  • K182914 — MC3 Vascular Access Kit 21030 (October 29, 2018)
  • K180151 — MC3 Jugular Dual Lumen Catheter (July 16, 2018)
  • K171610 — MC3 QuickFlow Dual Lumen Catheter (November 16, 2017)

Other clearances for product code BYS

  • K232767 — Nautilus VF ECMO Oxygenator (October 4, 2023)
  • K770720 — TUBING PACK, EXTRACORPOREAL, H-3000 (August 4, 1977)