PNO · Class II · 21 CFR 870.1250

FDA Product Code PNO: Catheter, Percutaneous, Cutting/scoring

To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material

Leading manufacturers include Angioscore, Inc., Cagent Vascular, LLC and Boston Scientific Ivt.

47
Total
47
Cleared
106d
Avg days
2004
Since
47 devices
25–47 of 47
Cleared Mar 04, 2015
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
K142983
Angioscore, Inc.
Cardiovascular · 139d
Cleared Apr 18, 2014
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
K133998
Angioscore, Inc.
Cardiovascular · 113d
Cleared Jan 11, 2013
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K122685
Angioscore, Inc.
Cardiovascular · 133d
Cleared May 22, 2012
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
K113103
Rex Medical
Cardiovascular · 216d
Cleared Aug 26, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K112182
Angioscore, Inc.
Cardiovascular · 29d
Cleared Apr 15, 2011
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K110767
Angioscore, Inc.
Cardiovascular · 28d
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Jul 14, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
K101735
Angioscore, Inc.
Cardiovascular · 23d
Cleared Mar 22, 2010
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY
K100303
Angioscore, Inc.
Cardiovascular · 47d
Cleared Jul 30, 2009
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
K091966
Angioscore, Inc.
Cardiovascular · 29d
Cleared Sep 11, 2008
VASCUTRAK 2, MODELS: V14 AND V18
K082343
Ymed, Inc.
Cardiovascular · 27d
Cleared Aug 11, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K082059
Angioscore, Inc.
Cardiovascular · 21d
Cleared May 28, 2008
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
K081220
Angioscore, Inc.
Cardiovascular · 28d
Cleared Apr 25, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
K080151
Angioscore, Inc.
Cardiovascular · 94d
Cleared Nov 09, 2007
VASCUTRAK II PTA DILATATION CATHETER
K073025
Thermopeutix, Inc. Dba Ymed, Inc.
Cardiovascular · 14d
Cleared Oct 12, 2007
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K072225
Angioscore, Inc.
Cardiovascular · 63d
Cleared Jun 04, 2007
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
K070951
Boston Scientific
Cardiovascular · 61d
Cleared Dec 12, 2006
VASCUTRAK PTA DILATION CATHETER
K063657
Ymed, Inc.
Cardiovascular · 4d
Cleared Oct 05, 2006
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
K062387
Boston Scientific
Cardiovascular · 51d
Cleared Sep 02, 2005
ANGIOSCULPT SCORING BALLOON CATHETER
K050629
Angioscore, Inc.
Cardiovascular · 175d
Cleared Jun 22, 2005
PERIPHERAL CUTTING BALLOON
K051254
Boston Scientific Ivt
Cardiovascular · 37d
Cleared Aug 16, 2004
2 CM PERIPHERAL CUTTING BALOON
K041993
Boston Scientific Ivt
Cardiovascular · 24d
Cleared Jul 01, 2004
PERIPHERAL CUTTING BALLOON
K040155
Boston Scientific Corp
Cardiovascular · 160d