# Terumo Cardiovascular Systems Thi Plant

- Location (FDA's records): Ann Arbor, MI
- FDA decisions: 1 (2025–2025): 1 510(k) clearance
- Product codes: NQQ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Lightlab Imaging, Inc.: 1 (https://510kreport.com/company/lightlab-imaging)

## Recent decisions
- K250684: OPUSWAVE Dual Sensor Imaging System (Jul 2, 2025)

Source page: https://510kreport.com/company/terumo-cardiovascular-systems-thi-plant