Data / Medical devices / United States / Terumo Cardiovascular Systems Thi Plant
Terumo Cardiovascular Systems Thi Plant: FDA-registered device maker in Ann Arbor, MI, United States, 1 510(k) clearance
Terumo Cardiovascular Systems Thi Plant is registered with the FDA (registration 3005228872) in Ann Arbor, MI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005228872
- Address
- 6190 Jackson Road, Ann Arbor, MI, United States, 48103
- Owner or operator
- TERUMO CARDIOVASCULAR SYSTEMS THI PLANT (9098362)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- November 20, 2007
- Registered through
- 2026
- Brand names listed
- OPUSWAVE Dual Sensor Imaging System, Ventricular bypass
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | 2 | Manufacturer | accessdata.fda.gov |
| Ventricular (Assist) Bypass | DSQ | 3 | Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 2, 2025 | K250684 | OPUSWAVE Dual Sensor Imaging System | NQQ | Substantially Equivalent | Terumo Cardiovascular Systems Thi Plant | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Optical Coherence Tomography (Oct)
- All makers of Ventricular (Assist) Bypass
Updated July 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.