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. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Feb 24, 2016

HeartLight Deflectable Sheath

Cardiovascular · 194d

Cleared Sep 20, 2001

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

Cardiovascular · 86d