Medical Device Manufacturer · US , Norton , MA

Cardiofocus, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2000

Recent clearances: HeartLight Deflectable Sheath, CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR, MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiofocus, Inc. General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared Mar 18, 2002

CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR

General & Plastic Surgery · 174d

Cleared Dec 20, 2001

MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)

General & Plastic Surgery · 24d

Cleared Feb 04, 2000

SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C

General & Plastic Surgery · 84d