MC3, Inc.
Dexter, MI, US
MC3, Inc. appears in FDA device records in Dexter, MI. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for MC3, Inc. between 2021 and 2023. The busiest year on record is 2021, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011468686 | 3011468686 | MC3, Inc. | 2555 Bishop Circle West, Dexter, MI 48130 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DREDilator, Vessel, For Percutaneous Catheterization
- PZSDual Lumen Ecmo Cannula
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- BYSOxygenator, Long Term Support Greater Than 6 Hours
- QHWSingle Lumen Ecmo Cannula
- FOXStand, Infusion
- QWFTubing, Long Term Support Greater Than 6 Hours
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1310-2024 | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E | May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer | Class II | Open, Classified | |
| Z-1309-2024 | NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E | May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain