FDA 510(k) Applications for Medical Device Product Code "PDU"
| 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 |
| K232562 | Baylis Medical Technologies Inc. | PowerWire Radiofrequency Guidewire Kit | 02/28/2024 |
| 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 |
| K251376 | LimFlow Inc. | LimFlow ARC | 05/31/2025 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
