FDA.reportPublic FDA data

TERUMO CARDIOVASCULAR SYSTEMS THI PLANT

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30052288723005228872TERUMO CARDIOVASCULAR SYSTEMS THI PLANT1N2026-01-016190 JACKSON ROAD Ann Arbor MI US 48103

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
743071906486859K250684OPUSWAVE Dual Sensor Imaging SystemNQQ2025-07-02
743071453562338

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQQ12025-07-02