TERUMO CARDIOVASCULAR SYSTEMS THI PLANT

FDA Device Registration & Listing · Ann Arbor, MI, US · Registration 3005228872

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005228872
FEI Number
3005228872
Entity Name
TERUMO CARDIOVASCULAR SYSTEMS THI PLANT
City/State/Country
Ann Arbor, MI, US
Establishment Address
6190 JACKSON ROAD, Ann Arbor, MI 48103, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TERUMO CARDIOVASCULAR SYSTEMS THI PLANT (Owner Number: 9098362)
Owner / Operator Contact Address
6190 Jackson Road, --, Ann Arbor, MI 48103, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250684
PMA Number
N/A

All Registered Proprietary Names

OPUSWAVE Dual Sensor Imaging System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2026-02-20

Official Correspondent

Lisa Hessabi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TERUMO CARDIOVASCULAR SYSTEMS THI PLANT
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K183320 St. Jude Medical (Now Abbott Medical) Ilumien Optis, Optis Integrated, Optis Mobile 2019-04-02
K253459 ABBOTT MEDICAL OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) 2026-04-24
K210458 ABBOTT MEDICAL OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System 2021-06-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005228872. Last updated year: 2026. Please use registration number 3005228872 when referencing this establishment in official correspondence.
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