FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K120273 |
AVINGER, INC. |
KITTYCAT CATHETER, KITTYCAT 2 CATHETER |
03/30/2012 |
K123462 |
AVINGER, INC. |
OCELOT CATHETER |
12/07/2012 |
K140185 |
AVINGER, INC. |
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE |
05/01/2014 |
K123532 |
AVINGER, INC. |
OCELOT PIXL CATHETER |
12/14/2012 |
K122380 |
AVINGER, INC. |
OCELOT SYSTEM |
11/07/2012 |
K201330 |
Avinger, Inc. |
Tigereye CTO-Crossing Catheter |
09/10/2020 |
K212468 |
Avinger, Inc. |
Tigereye CTO-Crossing Catheter |
01/06/2022 |
K230594 |
Avinger, Inc. |
Tigereye ST CTO-Crossing Catheter |
04/25/2023 |
K113838 |
AVINGER, INC. |
WILDCAT CATHETER |
03/12/2012 |
K111338 |
AVINGER, INC. |
WILDCAT CATHETER |
08/11/2011 |
K161208 |
Bard Peripheral Vacular, Inc. |
CROSSER CTO Recanalization Catheter |
05/24/2016 |
K101615 |
BAYLIS MEDICAL CO., INC. |
POWERWIRE RADIOFREQUENCY GUIDEWIRE |
07/28/2010 |
K051670 |
BAYLIS MEDICAL CO., INC. |
RF TUNNELER WIRE |
03/30/2006 |
K131914 |
BOSTON SCIENTIFIC CORP. |
OFFROAD RE-ENTRY CATHETER SYSTEM |
10/31/2013 |
K140288 |
BOSTON SCIENTIFIC CORP. |
TRUEPATH CTO DEVICE |
04/16/2014 |
K120533 |
BRIDGEPOINT MEDICAL |
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES |
05/22/2012 |
K203363 |
C.R. Bard, Inc. |
Crosser iQ CTO Recanalization System |
08/12/2021 |
K112308 |
C.R. BARD, INC. |
CROSSER RECANALIZATION SYSTEM |
08/17/2011 |
K082143 |
CORDIS CORP. |
MICRO GUIDE CATHETER XP |
08/25/2008 |
K140438 |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
MICRO GUIDE CATHETER ELITE |
11/14/2014 |
K083814 |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 |
01/13/2009 |
K150836 |
CORDIS CORPORATION, A JOHNSON & JOHNSON CO. |
OUTBACK Elite Re-Entry Catheter |
04/29/2015 |
K150187 |
Cordis Corporation, A Johnson & Johnson Company |
ELITECROSS Support Catheter |
05/19/2015 |
K091119 |
FLOWCARDIA, INC. |
MODIFICATION TO THE CROSSER SYSTEM |
05/15/2009 |
K092175 |
FLOWCARDIA, INC. |
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 |
02/17/2010 |
K072776 |
FLOWCARDIA, INC. |
THE CROSSER SYSTEM |
12/07/2007 |
K031842 |
INTRALUMINAL THERAPEUTICS, INC. |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
11/21/2003 |
K050916 |
INTRALUMINAL THERAPEUTICS, INC. |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] |
06/08/2005 |
K221541 |
LimFlow, Inc. |
LimFlow ARC |
08/31/2022 |
K023114 |
LUMEND, INC. |
LUMEND FRONTRUNNER CTO CATHETER |
01/23/2003 |
K033535 |
LUMEND, INC. |
LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES |
01/07/2004 |
K031005 |
LUMEND, INC. |
LUMEND FRONTRUNNER GW CTO CATHETER |
06/18/2003 |
K072155 |
MEDTRONIC INC. |
PIONEER CATHETER |
10/05/2007 |
K081804 |
MEDTRONIC INC. |
PIONEER PLUS CATHETER |
08/05/2008 |
K101777 |
MEDTRONIC VASCULAR |
PIONEER PLUS CATHETER, MODEL PLUS 120 |
07/23/2010 |
K162418 |
PHILIPS VOLCANO |
Pioneer Plus Catheter |
12/02/2016 |
K220544 |
Ra Medical Systems, Inc. |
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) |
06/29/2022 |
K210664 |
Ra Medical Systems, Inc. |
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) |
07/27/2021 |
K170349 |
Ra Medical Systems, Inc. |
RA-308 Excimer Laser System, Excimer Laser Catheter |
05/24/2017 |
K101599 |
REVASCULAR THERAPEUTICS, INC. |
RVT CTO DEVICE |
01/18/2011 |
K192211 |
SoundBite Medical Solution Inc. |
SoundBite Console, SoundBite Active Wire 18 |
01/17/2020 |
K210839 |
Soundbite Medical Solutions, Inc. |
SoundBite Crossing System - Peripheral (14P) |
04/20/2021 |
K230159 |
Soundbite Medical Solutions, Inc. |
SoundBite« Crossing System XS Peripheral |
08/28/2023 |
K043465 |
SPECTRANETICS CORP. |
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 |
08/18/2005 |
K071226 |
SPECTRANETICS CORP. |
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 |
06/29/2007 |
K040067 |
SPECTRANETICS CORP. |
CLIRPATH EXCIMER LASER CATHETER |
04/27/2004 |
K071227 |
SPECTRANETICS CORP. |
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 |
07/11/2007 |
K052296 |
SPECTRANETICS CORP. |
CLIRPATH TURBO EXCIMER LASER CATHETERS |
09/02/2005 |
K060012 |
SPECTRANETICS CORP. |
CLIRPATH TURBO PERIPHERAL CATHETERS |
09/29/2006 |
K052514 |
SPECTRANETICS CORP. |
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 |
10/19/2005 |
K221163 |
Tractus Vascular, LLC |
Tunnel Crossing Catheter |
01/19/2023 |
K211802 |
Upstream Peripheral Technologies, Ltd |
GoBack Crossing Catheter |
03/01/2022 |
K183357 |
XableCath, Inc. |
XableCath Crossing Catheter |
01/21/2019 |