Harmac Medical Products, Inc. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Harmac Medical Products, Inc. Cardiovascular ✕
6 devices
Cleared
Oct 16, 1997
HARMAC BALLOON ANGIOGRAPHIC CATHETER
Cardiovascular
475d
Cleared
Oct 16, 1997
HARMAC BALLOON WEDGE PRESSURE CATHETER
Cardiovascular
475d
Cleared
Oct 15, 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
Cardiovascular
474d
Cleared
Aug 14, 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
Cardiovascular
412d
Cleared
Aug 14, 1997
HARMAC THERMODILUTION CATHETER
Cardiovascular
412d
Cleared
Jun 25, 1997
HARMAC QUADPOLAR MAPPING PACING CATHETER
Cardiovascular
362d