MC3, Inc.

FDA Device Registration & Listing · Dexter, MI, US · Registration 3011468686

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011468686
FEI Number
3011468686
Entity Name
MC3, Inc.
City/State/Country
Dexter, MI, US
Establishment Address
2555 Bishop Circle West, Dexter, MI 48130, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Soft-Flow Extended Aortic Cannula VitalFlow Set with Balance Biosurface-OUS Nautilus™ VF ECMO Oxygenator MC3 Nautilus Smart ECMO Module with Balance Biosuface MC3 Nautilus ECMO Oxygenator with Balance Biosuface Bio-Medicus Life Support Catheter and Introducer Crescent™ Jugular Dual Lumen Catheter Vitalflow™ Console MC3 Vasular Access Kit VitalFlow™ Set with Balance™ Biosurface VitalFlow Console VitalFlow™ Console-OUS Power Cord Type F - CEE 7/7, 2.5 m-OUS Power Cord Type L – CEI 23-50, 2.5m-OUS VitalFlow™ Motor Drive-OUS VitalFlow™ Emergency Handcrank-OUS Power Cord Type K – AFSNIT 107-2-D1, 2.5m-OUS Power Cord Type J – SEV 1011, 2.5m-OUS VitalFlow™ Flow and Bubble Sensor-OUS Power Cord Type G – BS1363/A, 2.5m-OUS XPS Nexus VitalFlow ECMO Cart VitalFlow™ Centrifugal Pump MC3 Nautilus Oxygenator Holder

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-04-21
QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure Cardiovascular Class 2 870.4100 2025-07-22
BYS Oxygenator, Long Term Support Greater Than 6 Hours Cardiovascular Class 2 870.4100 2024-07-16
BYS Oxygenator, Long Term Support Greater Than 6 Hours Cardiovascular Class 2 870.4100 2024-04-21
QHW Single Lumen Ecmo Cannula Cardiovascular Class 2 870.4100 2026-02-13
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2026-02-13
PZS Dual Lumen Ecmo Cannula Cardiovascular Class 2 870.4100 2024-04-21
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular Class 2 870.4100 2024-07-16
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2024-04-21
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular Class 2 870.4100 2024-09-13
BYS Oxygenator, Long Term Support Greater Than 6 Hours Cardiovascular Class 2 870.4100 2024-09-13
QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure Cardiovascular Class 2 870.4100 2024-09-13
QWF Tubing, Long Term Support Greater Than 6 Hours Cardiovascular Class 2 870.4100 2024-09-13
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular Class 2 870.4100 2025-08-13
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular Class 2 870.4100 2025-07-22
FOX Stand, Infusion General Hospital Class 1 880.6990 1992-12-21
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use Cardiovascular Class 2 870.4100 2024-09-18
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2003-06-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K832124 Med-West, Inc. CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 1983-08-12
K162500 Spyder Medical Ostial Sprit Cannulae 2017-01-12
K234118 ABBOTT MEDICAL CentriMag™ Acute Circulatory Support System 2024-01-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2022 Medtronic Perfusion Systems 2
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018 OriGen Biomedical, Inc. 2
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011468686. Last updated year: 2026. Please use registration number 3011468686 when referencing this establishment in official correspondence.
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