Angioscore, Inc. - FDA 510(k) Cleared Devices
Recent clearances: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating, ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING, ANGIOSCULPT PTA SCORING BALLOON CATHETER
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Angioscore, Inc. Cardiovascular ✕
13 devices
Cleared
Mar 04, 2015
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
Cardiovascular
139d
Cleared
Apr 18, 2014
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
Cardiovascular
113d
Cleared
Jan 11, 2013
ANGIOSCULPT PTA SCORING BALLOON CATHETER
Cardiovascular
133d
Cleared
Aug 26, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
Cardiovascular
29d
Cleared
Apr 15, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
Cardiovascular
28d
Cleared
Jul 14, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
Cardiovascular
23d
Cleared
Mar 22, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY,...
Cardiovascular
47d
Cleared
Jul 30, 2009
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
Cardiovascular
29d
Cleared
Aug 11, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER
Cardiovascular
21d
Cleared
May 28, 2008
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
Cardiovascular
28d
Cleared
Apr 25, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
Cardiovascular
94d
Cleared
Oct 12, 2007
ANGIOSCULPT PTA SCORING BALLOON CATHETER
Cardiovascular
63d