FDA 510(k) Applications Submitted by CARDIOFOCUS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K013201 09/25/2001 CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR CARDIOFOCUS, INC.
K011988 06/26/2001 SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C CARDIOFOCUS, INC.
K013901 11/26/2001 MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) CARDIOFOCUS, INC.
K152310 08/14/2015 HeartLight Deflectable Sheath CARDIOFOCUS, INC.
K993834 11/12/1999 SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C CARDIOFOCUS, INC.


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