Catheter For Crossing Total Occlusions
FDA product code PDU · Class II (moderate risk) · 21 CFR 870.1250 · Cardiovascular
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
58510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Avinger, Inc. 10
- Spectranetics Corp. 7
- Lumend, Inc. 3
- Flowcardia, Inc. 3
- Ra Medical Systems, Inc. 3
- Soundbite Medical Solutions, Inc. 2
- LimFlow, Inc. 2
- Baylis Medical Technologies, Inc. 2
- Cordis Corporation, A Johnson & Johnson Company 2
- Boston Scientific Corporation 2
- C.R. Bard, Inc. 2
- Cordis Corp., A Johnson & Johnson Co. 2
- Medtronic, Inc. 2
- Baylis Medical Co., Inc. 2
- Intra Luminal Therapeutics, Inc. 2
- Revascular Therapeutics, Inc. 1
- Bridgepoint Medical 1
- Medtronic Vascular 1
- Reflow Medical 1
- Philips Volcano 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262013 | Kiba CTO Crossing CatheterPDU · Special | Reflow Medical, Inc. | 08/28/2026SE |
| K252315 | Santreva-ATK Endovascular Revasculariztion CatheterPDU · Traditional | AngioSafe, Inc. | 09/22/2025SE |
| K251158 | PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 09/11/2025SESK |
| K251376 | LimFlow ARCPDU · Special | LimFlow, Inc. | 05/31/2025SE |
| K232562 | PowerWire Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 02/28/2024SESK |
| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 04/25/2023SE |
| K221163 | Tunnel Crossing CatheterPDU · Traditional | Tractus Vascular, LLC | 01/19/2023SE |
| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | Ra Medical Systems,Inc | 06/29/2022SE |
| K211802 | GoBack Crossing CatheterPDU · Traditional | Upstream Peripheral Technologies, Ltd. | 03/01/2022SE |
| K212468 | Tigereye CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 01/06/2022SE |
| K203363 | Crosser iQ CTO Recanalization SystemPDU · Traditional | C.R. Bard, Inc. | 08/12/2021SE |
| K210664 | DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)PDU · Traditional | Ra Medical Systems,Inc | 07/27/2021SE |
| K210839 | SoundBite Crossing System - Peripheral (14P)PDU · Special | Soundbite Medical Solutions, Inc. | 04/20/2021SE |
| K201330 | Tigereye CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 09/10/2020SE |
| K192211 | SoundBite Console, SoundBite Active Wire 18PDU · Traditional | Soundbite Medical Solution, Inc. | 01/17/2020SE |
| K183357 | XableCath Crossing CatheterPDU · Traditional | Xablecath, Inc. | 01/21/2019SE |
| K170349 | RA-308 Excimer Laser System, Excimer Laser CatheterPDU · Traditional | Ra Medical Systems,Inc | 05/24/2017SE |
| K162418 | Pioneer Plus CatheterPDU · Special | Philips Volcano | 12/02/2016SE |
| K161208 | CROSSER CTO Recanalization CatheterPDU · Special | Bard Peripheral Vacular, Inc. | 05/24/2016SE |
| K150187 | ELITECROSS Support CatheterPDU · Traditional | Cordis Corporation, A Johnson & Johnson Company | 05/19/2015SE |
| K150836 | OUTBACK Elite Re-Entry CatheterPDU · Special | Cordis Corporation, A Johnson & Johnson Co. | 04/29/2015SE |
| K140438 | Micro Guide Catheter ElitePDU · Traditional | Cordis Corp., A Johnson & Johnson Co. | 11/14/2014SE |
| K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsolePDU · Traditional | Avinger, Inc. | 05/01/2014SE |
| K140288 | Truepath Cto DevicePDU · Special | Boston Scientific Corp | 04/16/2014SE |
| K131914 | Offroad Re-Entry Catheter SystemPDU · Traditional | Boston Scientific Corp | 10/31/2013SE |
| K123532 | Ocelot Pixl CatheterPDU · Special | Avinger, Inc. | 12/14/2012SE |
| K123462 | Ocelot CatheterPDU · Special | Avinger, Inc. | 12/07/2012SE |
| K122380 | Ocelot SystemPDU · Traditional | Avinger, Inc. | 11/07/2012SE |
| K120533 | Bigboss Catheters Mantatay Catheter Mantaray GuidewiresPDU · Traditional | Bridgepoint Medical | 05/22/2012SE |
| K120273 | Kittycat Catheter, Kittycat 2 CatheterPDU · Traditional | Avinger, Inc. | 03/30/2012SE |
| K113838 | Wildcat CatheterPDU · Traditional | Avinger, Inc. | 03/12/2012SE |
| K112308 | Crosser Recanalization SystemPDU · Traditional | C.R. Bard, Inc. | 08/17/2011SE |
| K111338 | Wildcat CatheterPDU · Traditional | Avinger, Inc. | 08/11/2011SE |
| K101599 | RVT Cto DevicePDU · Traditional | Revascular Therapeutics, Inc. | 01/18/2011SE |
| K101615 | Powerwire Radiofrequency GuidewirePDU · Special | Baylis Medical Co., Inc. | 07/28/2010SE |
| K101777 | Pioneer Plus Catheter, Model Plus 120PDU · Special | Medtronic Vascular | 07/23/2010SE |
| K092175 | The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200PDU · Traditional | Flowcardia, Inc. | 02/17/2010SE |
| K091119 | Modification to the Crosser SystemPDU · Special | Flowcardia, Inc. | 05/15/2009SE |
| K083814 | Outback Ltd Re-Entry Catheter, Model: OTB42120PDU · Traditional | Cordis Corp., A Johnson & Johnson Co. | 01/13/2009SE |
| K082143 | Micro Guide Catheter XPPDU · Special | Cordis Corp. | 08/25/2008SE |
| K081804 | Pioneer Plus CatheterPDU · Traditional | Medtronic, Inc. | 08/05/2008SE |
| K072776 | The Crosser SystemPDU · Traditional | Flowcardia, Inc. | 12/07/2007SE |
| K072155 | Pioneer CatheterPDU · Traditional | Medtronic, Inc. | 10/05/2007SE |
| K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…PDU · Traditional | Spectranetics Corp. | 07/11/2007SE |
| K071226 | 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043PDU · Traditional | Spectranetics Corp. | 06/29/2007SE |
| K060012 | Clirpath Turbo Peripheral CathetersPDU · Traditional | Spectranetics Corp. | 09/29/2006SE |
| K051670 | RF Tunneler WirePDU · Traditional | Baylis Medical Co., Inc. | 03/30/2006SE |
| K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…PDU · Traditional | Spectranetics Corp. | 10/19/2005SE |
| K052296 | Clirpath Turbo Excimer Laser CathetersPDU · Traditional | Spectranetics Corp. | 09/02/2005SE |
| K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011PDU · Traditional | Spectranetics Corp. | 08/18/2005SE |
| K050916 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]PDU · Special | Intra Luminal Therapeutics, Inc. | 06/08/2005SE |
| K040067 | Clirpath Excimer Laser CatheterPDU · Traditional | Spectranetics Corp. | 04/27/2004SE |
| K033535 | Lumend Frontrunner Cto Catheter and AccessoriesPDU · Special | Lumend, Inc. | 01/07/2004SE |
| K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing SystemPDU · Traditional | Intra Luminal Therapeutics, Inc. | 11/21/2003SE |
| K031005 | Lumend Frontrunner GW Cto CatheterPDU · Special | Lumend, Inc. | 06/18/2003SE |
| K023114 | Lumend Frontrunner Cto CatheterPDU · Traditional | Lumend, Inc. | 01/23/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0676-2024 Class II | BD Recanalization System, REF: BDRECANSYSTEMRecanalization systems may be in a manufacturing mode that allows the system to continuously run without the… | Bard Peripheral Vascular Inc | 11/14/2023Open, Classified |
| Z-0569-2021 Class II | DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in…Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If… | Ra Medical Systems, Inc. | 10/16/2020Terminated |
| Z-0050-2021 Class II | DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use…Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient… | Ra Medical Systems, Inc. | 07/24/2020Terminated |
| Z-2497-2020 Class II | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer…A software issue was identified which could result in user or patient injury, or may adversely impact laser… | Ra Medical Systems, Inc. | 01/23/2020Terminated |
| Z-2006-2020 Class II | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE…The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter… | Ra Medical Systems, Inc. | 09/19/2019Terminated |
| Z-2218-2019 Class II | The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy…Lasers/Catheters did not calibrate during set-up prior to use. | Ra Medical Systems Inc | 02/15/2018Terminated |
| Z-2718-2015 Class II | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing…Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter… | Volcano Corporation | 07/22/2015Terminated |