FDA.reportPublic FDA data

XVIVO PERFUSION, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097369253009736925XVIVO PERFUSION, INC.1N2026-01-0116080 Table Mountain Pkwy Ste 500 Golden CO US 80403
30289078623028907862XVIVO PERFUSION, INC.1Y2026-01-013250 Quentin Street, Suite #134 Aurora CO US 80011
30097369253009736925XVIVO PERFUSION, INC.1Y2020-04-253666 S Inca Street Englewood CO US 80110

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3210121184693402P180014XPS™ with Steen Solution™ PerfusatePHO2019-04-26
3210131184693402P180014XPS™ with Steen Solution™ PerfusatePHO2019-04-26
1432351254744487P180014XPS™ with Steen Solution™ PerfusatePHO2019-04-26
1432351773579814K170826Perfadex PlusKDN2018-06-22
1432351826216536

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PHO32019-04-26
KDN12018-06-22

PMA#