FDA.reportPublic FDA data

Nuwellis, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30071377873007137787Nuwellis, Inc.1N2026-01-0112988 Valley View Rd Eden Prairie MN US 55344

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
926881323911929K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)NQJ2025-08-13
926881840102354K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)NQJ2023-12-26
926881713892119K192756Aquadex FlexFlow System 2.0KDI2020-02-24
926881000195914K071854AQUADEX FLEXFLOW SYSTEMKDI2007-09-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI42020-02-24
NQJ22025-08-13

PMN#