# Cardio-Optics, Inc.

- Location (FDA's records): Boulder, CO
- FDA decisions: 2 (2005–2006): 2 510(k) clearances
- Product codes: LYK (2)
- Predicates its devices cite: 11 (1 its own); citations of its devices by later devices: 1 (1 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
- Olympus Corp.: 4 (https://510kreport.com/company/olympus)
- Cordis Webster, Inc.: 1 (https://510kreport.com/company/cordis-webster)
- St Jude Medical: 1 (https://510kreport.com/company/st-jude-medical)
- Thomas Medical Products, Inc.: 1 (https://510kreport.com/company/thomas-medical-products)
- Acumen Medical, Inc.: 1 (https://510kreport.com/company/acumen-medical)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Ep Medsystems: 1 (https://510kreport.com/company/ep-medsystems)

## Its most-cited devices
- K050808: Coronary Sinus Access Kit, Model KCS8F-01 (2005), cited by 1

## Recent decisions
- K062340: Cardiooptics Augmentative Cardiac Optical Imaging System (Nov 30, 2006)
- K050808: Coronary Sinus Access Kit, Model KCS8F-01 (Jul 28, 2005)

Source page: https://510kreport.com/company/cardio-optics