Data / Medical devices / United States / MC3, Inc.

MC3, Inc.: FDA-registered device maker in Dexter, MI, United States, 13 510(k) clearances

Name: MC3, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

MC3, Inc. is registered with the FDA (registration 3011468686) in Dexter, MI, United States. It lists 10 device types. The FDA files 13 510(k) clearances under its listings, the newest dated July 31, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011468686
Address: 2555 Bishop Circle West, Dexter, MI, United States, 48130
Owner or operator: Medtronic, Inc. (2112641)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
First device listed: December 21, 1992
Registered through: 2027
Brand names listed: Bio-Medicus Life Support Catheter and Introducer, Crescent RA Dual Lumen Catheter, Crescent Jugular Dual Lumen Catheter, MC3 Nautilus ECMO Oxygenator with Balance Biosuface, MC3 Nautilus Oxygenator Holder, MC3 Nautilus Smart ECMO Module with Balance Biosuface, MC3 Vasular Access Kit, Nautilus VF ECMO Oxygenator and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory Equipment, Cardiopulmonary Bypass	KRI	1	Manufacturer	accessdata.fda.gov
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	QNR	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Manufacturer	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Manufacturer	accessdata.fda.gov
Dual Lumen Ecmo Cannula	PZS	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	QJZ	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Oxygenator, Long Term Support Greater Than 6 Hours	BYS	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Single Lumen Ecmo Cannula	QHW	2	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Complaint file establishment	accessdata.fda.gov
Tubing, Long Term Support Greater Than 6 Hours	QWF	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 31, 2026	K261335	VitalFlow Set with Balance Biosurface	QJZ	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
January 15, 2026	K251831	Bio-Medicus Life Support Catheter and Introducer	QHW	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
May 20, 2025	K250199	VitalFlow Console	QNR	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
September 12, 2024	K240880	VitalFlow Set with Balance Biosurface	QJZ	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
October 4, 2023	K232767	Nautilus VF ECMO Oxygenator	BYS	Substantially Equivalent	Mc3, Inc.	accessdata.fda.gov
August 25, 2023	K230364	VitalFlow Console	QNR	Substantially Equivalent	Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)	accessdata.fda.gov
August 25, 2023	K223898	VitalFlowTM Centrifugal Pump	QNR	Substantially Equivalent	Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)	accessdata.fda.gov
May 3, 2021	K203409	MC3 Crescent Jugular Dual Lumen Catheter	PZS	Substantially Equivalent	Mc3, Inc.	accessdata.fda.gov
April 9, 2020	K191935	Nautilus Smart ECMO Module	BYS	Substantially Equivalent	Mc3 Incorporated	accessdata.fda.gov
October 29, 2018	K182914	MC3 Vascular Access Kit 21030	DRE	Substantially Equivalent	Mc3 Incorporated	accessdata.fda.gov
July 16, 2018	K180151	MC3 Jugular Dual Lumen Catheter	PZS	Substantially Equivalent	Mc3 Incorporated	accessdata.fda.gov
February 27, 2014	K132811	SARNS SOFT-FLOW EXTENDED AORTIC CANNULA	DWF	Substantially Equivalent	Terumo Cardiovascular Systems Corporation	accessdata.fda.gov
February 18, 2014	K132451	SARNS SOFT-FLOW AORTIC CANNULA	DWF	Substantially Equivalent	Terumo Cardiovascular Systems Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 11, 2023	94016	Class II	Ongoing	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	accessdata.fda.gov

Compare with other makers

Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.