FDA.reportPublic FDA data

MC3, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30114686863011468686MC3, Inc.1N2026-01-012555 Bishop Circle West Dexter MI US 48130

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3280291251627815K261335VitalFlow Set with Balance™ BiosurfaceQJZ2026-07-31
3280291250687813K251831Bio-Medicus Life Support Catheter and IntroducerQHW2026-01-15
3280291391201367K250199VitalFlow ConsoleQNR2025-05-20
3280291441542376K240880VitalFlow Set with Balance BiosurfaceQJZ2024-09-12
3280291146492939K232767Nautilus VF ECMO OxygenatorBYS2023-10-04
3280291615816415K230364VitalFlow™ ConsoleQNR2023-08-25
3280291756491347K223898VitalFlowTM Centrifugal PumpQNR2023-08-25
3280291032359830K203409MC3 Crescent Jugular Dual Lumen CatheterPZS2021-05-03
3280291420659298K191935Nautilus Smart ECMO ModuleBYS2020-04-09
3280291893801707K182914MC3 Vascular Access Kit 21030DRE2018-10-29
3280291145176612K180151MC3 Jugular Dual Lumen CatheterPZS2018-07-16
3280291702792504K132811SARNS SOFT-FLOW EXTENDED AORTIC CANNULADWF2014-02-27
3280291881581692K132451SARNS SOFT-FLOW AORTIC CANNULADWF2014-02-18
3280291182839492
3280291512984068
3280291652038630
3280291678317053
3280291967084969
3280291999419425

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QNR32025-05-20
QJZ22026-07-31
BYS22023-10-04
PZS22021-05-03
DWF22014-02-27
QHW12026-01-15
DRE12018-10-29

PMN#