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510(k) K232767

Nautilus VF ECMO Oxygenator by Mc3, Inc. — Product Code BYS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2023
Date Received
September 11, 2023
Clearance Type
Special
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, Inc.

  • K203409 — MC3 Crescent Jugular Dual Lumen Catheter (May 3, 2021)

Other clearances for product code BYS

  • K191935 — Nautilus Smart ECMO Module (April 9, 2020)
  • K770720 — TUBING PACK, EXTRACORPOREAL, H-3000 (August 4, 1977)