Nautilus VF ECMO Oxygenator— 510(k) K232767

Name: FDA 510(k) clearance K232767
Creator: U.S. Food and Drug Administration
Published: 2023-10-04

Substantially Equivalent

Mc3, Inc.

FDA 510(k) clearance K232767 for Nautilus VF ECMO Oxygenator, Substantially Equivalent on 2023-10-04. Applicant: Mc3, Inc.. Device class: 2.

Clearance details

Applicant: Mc3, Inc.
Product code: Code BYS
Device class: Class 2
Regulation: 21 CFR 870.4100
Advisory panel: Cardiovascular
Date received: 2023-09-11
Decision date: 2023-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Dexter, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYS

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K191935 — Nautilus Smart ECMO Module2020-04-09
K770720 — TUBING PACK, EXTRACORPOREAL, H-30001977-08-04

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K203409 — MC3 Crescent Jugular Dual Lumen Catheter2021-05-03

Adverse events under product code BYS

product code BYS

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.