Cardiofocus, Inc. is one of 4826 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cardiofocus, Inc. - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Cardiofocus, Inc. has 5 FDA 510(k) cleared medical devices. Based in Norton, US.
Historical record: 5 cleared submissions from 2000 to 2016. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Cardiofocus, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Cardiofocus, Inc.
5 devices
Cleared
Feb 24, 2016
HeartLight Deflectable Sheath
Cardiovascular
194d
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
Sep 20, 2001
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
Cardiovascular
86d
Cleared
Feb 04, 2000
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
General & Plastic Surgery
84d