Mc3 Inc
FDA Regulatory Profile
Mc3 Inc has 2 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1310-2024 · Class II · Oct 11, 2023
- Latest inspection
- Dec 19, 2017 · NAI
- Latest 510(k)
- Oct 4, 2023
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 2 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 6 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 1 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1310-2024 | Class II | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures… | Oct 11, 2023 |
| Z-1309-2024 | Class II | NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to… | Oct 11, 2023 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Dec 19, 2017 | Dexter, MI | Devices | No Action Indicated (NAI) | 3011468686 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232767 | Nautilus VF ECMO Oxygenator | Oct 4, 2023 |
| K203409 | MC3 Crescent Jugular Dual Lumen Catheter | May 3, 2021 |
| K191935 | Nautilus Smart ECMO Module | Apr 9, 2020 |
| K182914 | MC3 Vascular Access Kit 21030 | Oct 29, 2018 |
| K180151 | MC3 Jugular Dual Lumen Catheter | Jul 16, 2018 |
| K171610 | MC3 QuickFlow Dual Lumen Catheter | Nov 16, 2017 |