Medical Device Manufacturer · US , Boulder , CO

Cardio-Optics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2005

Recent clearances: CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM, CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardio-Optics, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Nov 30, 2006

CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM

Cardiovascular · 112d

Cleared Jul 28, 2005

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

Cardiovascular · 120d