Panels › Cardiovascular › Product code PDU · Class 2
Catheter For Crossing Total Occlusions
Regulation 870.1250
1510(k)s in 12 months (58 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in PDU
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2026 | K262013 | Kiba CTO Crossing Catheter Reflow Medical, Inc. | PDU |
| Sep 22, 2025 | K252315 | Santreva-ATK Endovascular Revasculariztion Catheter AngioSafe, Inc. | PDU |
| Sep 11, 2025 | K251158 | PowerWire® 14 Radiofrequency Guidewire Kit Baylis Medical Technologies, Inc., CA | PDU |
| May 31, 2025 | K251376 | LimFlow ARC LimFlow, Inc. | PDU |
| Feb 28, 2024 | K232562 | PowerWire Radiofrequency Guidewire Kit Baylis Medical Technologies, Inc., CA | PDU |
| Aug 28, 2023 | K230159 | SoundBite® Crossing System XS Peripheral Soundbite Medical Solutions, Inc., CA | PDU |
| Apr 25, 2023 | K230594 | Tigereye ST CTO-Crossing Catheter Avinger, Inc. | PDU |
| Jan 19, 2023 | K221163 | Tunnel Crossing Catheter Tractus Vascular, LLC | PDU |
| Aug 31, 2022 | K221541 | LimFlow ARC LimFlow, Inc. | PDU |
| Jun 29, 2022 | K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) Ra Medical Systems,Inc | PDU |
| Mar 1, 2022 | K211802 | GoBack Crossing Catheter Upstream Peripheral Technologies, Ltd., IL | PDU |
| Jan 6, 2022 | K212468 | Tigereye CTO-Crossing Catheter Avinger, Inc. | PDU |
| Aug 12, 2021 | K203363 | Crosser iQ CTO Recanalization System C.R. Bard, Inc. | PDU |
| Jul 27, 2021 | K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) Ra Medical Systems,Inc | PDU |
| Apr 20, 2021 | K210839 | SoundBite Crossing System - Peripheral (14P) Soundbite Medical Solutions, Inc., CA | PDU |
| Sep 10, 2020 | K201330 | Tigereye CTO-Crossing Catheter Avinger, Inc. | PDU |
| Jan 17, 2020 | K192211 | SoundBite Console, SoundBite Active Wire 18 Soundbite Medical Solution, Inc., CA | PDU |
| Jan 21, 2019 | K183357 | XableCath Crossing Catheter Xablecath, Inc. | PDU |
| May 24, 2017 | K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter Ra Medical Systems,Inc | PDU |
| Dec 2, 2016 | K162418 | Pioneer Plus Catheter Philips Volcano | PDU |
| May 24, 2016 | K161208 | CROSSER CTO Recanalization Catheter Bard Peripheral Vacular, Inc. | PDU |
| May 19, 2015 | K150187 | ELITECROSS Support Catheter Cordis Corporation, A Johnson & Johnson Company | PDU |
| Apr 29, 2015 | K150836 | OUTBACK Elite Re-Entry Catheter Cordis Corporation, A Johnson & Johnson Co. | PDU |
| Nov 14, 2014 | K140438 | MICRO GUIDE CATHETER ELITE Cordis Corp., A Johnson & Johnson Co. | PDU |
| May 1, 2014 | K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE Avinger, Inc. | PDU |
| Apr 16, 2014 | K140288 | TRUEPATH CTO DEVICE Boston Scientific Corp | PDU |
| Oct 31, 2013 | K131914 | OFFROAD RE-ENTRY CATHETER SYSTEM Boston Scientific Corp | PDU |
| Dec 14, 2012 | K123532 | OCELOT PIXL CATHETER Avinger, Inc. | PDU |
| Dec 7, 2012 | K123462 | OCELOT CATHETER Avinger, Inc. | PDU |
| Nov 7, 2012 | K122380 | OCELOT SYSTEM Avinger, Inc. | PDU |
| May 22, 2012 | K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES Bridgepoint Medical | PDU |
| Mar 30, 2012 | K120273 | KITTYCAT CATHETER, KITTYCAT 2 CATHETER Avinger, Inc. | PDU |
| Mar 12, 2012 | K113838 | WILDCAT CATHETER Avinger, Inc. | PDU |
| Aug 17, 2011 | K112308 | CROSSER RECANALIZATION SYSTEM C.R. Bard, Inc. | PDU |
| Aug 11, 2011 | K111338 | WILDCAT CATHETER Avinger, Inc. | PDU |
| Jan 18, 2011 | K101599 | RVT CTO DEVICE Revascular Therapeutics, Inc. | PDU |
| Jul 28, 2010 | K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE Baylis Medical Co., Inc., CA | PDU |
| Jul 23, 2010 | K101777 | PIONEER PLUS CATHETER, MODEL PLUS 120 Medtronic Vascular | PDU |
| Feb 17, 2010 | K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 Flowcardia, Inc. | PDU |
| May 15, 2009 | K091119 | MODIFICATION TO THE CROSSER SYSTEM Flowcardia, Inc. | PDU |
| Jan 13, 2009 | K083814 | OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 Cordis Corp., A Johnson & Johnson Co. | PDU |
| Aug 25, 2008 | K082143 | MICRO GUIDE CATHETER XP Cordis Corp. | PDU |
| Aug 5, 2008 | K081804 | PIONEER PLUS CATHETER Medtronic, Inc. | PDU |
| Dec 7, 2007 | K072776 | THE CROSSER SYSTEM Flowcardia, Inc. | PDU |
| Oct 5, 2007 | K072155 | PIONEER CATHETER Medtronic, Inc. | PDU |
| Jul 11, 2007 | K071227 | CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 Spectranetics Corp. | PDU |
| Jun 29, 2007 | K071226 | 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 Spectranetics Corp. | PDU |
| Sep 29, 2006 | K060012 | CLIRPATH TURBO PERIPHERAL CATHETERS Spectranetics Corp. | PDU |
| Mar 30, 2006 | K051670 | RF TUNNELER WIRE Baylis Medical Co., Inc., CA | PDU |
| Oct 19, 2005 | K052514 | CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 Spectranetics Corp. | PDU |
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