FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K072225 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
10/12/2007 |
K082059 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
08/11/2008 |
K122685 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
01/11/2013 |
K110767 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
04/15/2011 |
K112182 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
08/26/2011 |
K100303 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY |
03/22/2010 |
K101735 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY |
07/14/2010 |
K142983 |
ANGIOSCORE, INC. |
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating |
03/04/2015 |
K080151 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 |
04/25/2008 |
K091966 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 |
07/30/2009 |
K133998 |
ANGIOSCORE, INC. |
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING |
04/18/2014 |
K050629 |
ANGIOSCORE, INC. |
ANGIOSCULPT SCORING BALLOON CATHETER |
09/02/2005 |
K081220 |
ANGIOSCORE, INC. |
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER |
05/28/2008 |
K163420 |
BARD PERIPHERAL VASCULAR, INC. |
UltraScore Focused Force PTA Balloon |
06/14/2017 |
K070951 |
BOSTON SCIENTIFIC |
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS |
06/04/2007 |
K062387 |
BOSTON SCIENTIFIC |
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM |
10/05/2006 |
K040155 |
BOSTON SCIENTIFIC CORP. |
PERIPHERAL CUTTING BALLOON |
07/01/2004 |
K041993 |
BOSTON SCIENTIFIC IVT |
2 CM PERIPHERAL CUTTING BALOON |
08/16/2004 |
K051254 |
BOSTON SCIENTIFIC IVT |
PERIPHERAL CUTTING BALLOON |
06/22/2005 |
K151253 |
BOSTON SCIENTIFIC LIMITED |
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter |
06/10/2015 |
K103459 |
C. R. BARD, INC. |
VASCUTRAK PTA DILATATION CATHETER |
12/13/2010 |
K172571 |
C.R. Bard |
ULTRASCORE Focused Force PTA Balloon |
09/22/2017 |
K163380 |
Cagent Vascular, LLC |
Serranator Alto PTA Serration Balloon Catheter |
02/13/2017 |
K193181 |
Cagent Vascular, LLC |
Serranator PTA Serration Balloon Catheter |
04/15/2020 |
K203437 |
Cagent Vascular, LLC |
Serranator PTA Serration Balloon Catheter |
12/22/2020 |
K213728 |
Cagent Vascular, LLC |
Serranator PTA Serration Balloon Catheter |
12/15/2021 |
K220704 |
Cagent Vascular, LLC |
Serranator PTA Serration Balloon Catheter |
05/04/2022 |
K141322 |
COOK INCORPORATED |
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER |
03/27/2015 |
K182713 |
OrbusNeich Medical Trading, Inc. |
Scoreflex PTA Scoring Balloon Catheter |
06/11/2019 |
K113103 |
REX MEDICAL |
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE |
05/22/2012 |
K150634 |
Spectranetrics |
AngioSculpt PTA Scoring Baloon Catheters |
04/08/2015 |
K073025 |
THERMOPEUTIX INC. DBA YMED INC. |
VASCUTRAK II PTA DILATATION CATHETER |
11/09/2007 |
K193495 |
Transit Scientific |
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter |
05/29/2020 |
K221986 |
Transit Scientific, LLC |
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter |
10/18/2022 |
K152789 |
VENTUREMED GROUP |
FLEX SCORING CATHETER |
05/25/2016 |
K202187 |
VentureMed Group, Inc. |
FLEX Vessel Prep System |
09/11/2020 |
K082343 |
YMED INC. |
VASCUTRAK 2, MODELS: V14 AND V18 |
09/11/2008 |
K063657 |
YMED INC. |
VASCUTRAK PTA DILATION CATHETER |
12/12/2006 |