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 Bard Peripheral Vascular, Inc..

45
Total
45
Cleared
103d
Avg days
2004
Since
45 devices
25–45 of 45
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 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 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