FDA.reportPublic FDA data

TORAY INDUSTRIES, INC. SETA PLANT

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96128123002808331TORAY INDUSTRIES, INC. SETA PLANT1N2026-01-011-1, OE 1-CHOME OTSU Shiga JP 520-2141

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
160021148631715P910054INOUE BALLOON CATHETERMAD1994-06-28
160021277817256K220881INOUE BALLOON AOZT2022-12-18
160021036395218K042370TORAYGUIDE GUIDEWIREDQX2004-12-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OZT12022-12-18
DQX12004-12-17
MAD11994-06-28