Spectranetics Corp.
Medical device manufacturer in Colorado Springs, CO.
43510(k) clearances
4PMA approvals
21recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | 03/13/2025SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | 12/15/2022SE |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 12/08/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | 08/24/2022SE |
| K203540 | Bridge Occlusion BalloonMJN · Special | 12/23/2020SE |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 04/05/2018SE |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Traditional | 11/27/2017SE |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW · Traditional | 04/07/2017SE |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW · Traditional | 01/05/2017SE |
| K161333 | TightRail Sub-C Rotating Dilator SheathDRE · Traditional | 07/08/2016SE |
| K153530 | Bridge Occlusion BalloonMJN · Traditional | 02/05/2016SE |
| K152181 | Turbo-Power Laser Atherectomy CatheterMCW · Traditional | 11/12/2015SE |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathDRE · Special | 03/04/2015SE |
| K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support CatheterDQY · Special | 02/27/2015SE |
| K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathDRE · Traditional | 09/25/2014SE |
| K142116 | LLD EzDRB · Special | 08/12/2014SE |
| K140775 | Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemMCW · Traditional | 07/23/2014SE |
| K141131 | Tightrail MiniDRE · Special | 05/23/2014SE |
| K140047 | Lexiconture Mechanical Dilator Sheath SetDRE · Traditional | 04/09/2014SE |
| K133631 | Lexipliant Dilator Sheath SetDRE · Traditional | 03/27/2014SE |
| K123632 | 2.5MM Turbo Elite 035, 2.3MM Turbo Elite 035MCW · Traditional | 01/25/2013SE |
| K112032 | 8FR Turbo - Tandem SystemDQY · Traditional | 10/17/2011SE |
| K093257 | Torqmax Sheath Grip AccessoryOFC · Traditional | 03/26/2010SE |
| K094036 | Turbo-Tandem System Model 472-110MCW · Special | 01/25/2010SE |
| K092378 | Spectranetics Visisheath Dilator SheathDRE · Traditional | 11/02/2009SE |
| K092396 | Spectranetics Quick Cross Extreme Support CathetersDQY · Special | 09/04/2009SE |
| K091299 | Spectranetics Turbo-Tandem SystemDQY · Traditional | 07/01/2009SE |
| K090913 | Cross-Pilot Turbo Elite Support CatheterDQY · Traditional | 05/04/2009SE |
| K082559 | Spectranetics Cross-Pilot Turbo Elite Support CatheterDQY · Traditional | 12/11/2008SE |
| K082561 | Spectranetics Quick-Cross Extreme Support CathetersDQY · Traditional | 12/10/2008SE |
| K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066DQY · Special | 12/04/2007SE |
| K071227 | Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…PDU · Traditional | 07/11/2007SE |
| K071226 | 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043PDU · Traditional | 06/29/2007SE |
| K060012 | Clirpath Turbo Peripheral CathetersPDU · Traditional | 09/29/2006SE |
| K052514 | Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…PDU · Traditional | 10/19/2005SE |
| K052296 | Clirpath Turbo Excimer Laser CathetersPDU · Traditional | 09/02/2005SE |
| K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011PDU · Traditional | 08/18/2005SE |
| K043401 | Spectranetics LLD CS, Model 518-039DRB · Traditional | 03/16/2005SE |
| K040067 | Clirpath Excimer Laser CatheterPDU · Traditional | 04/27/2004SE |
| K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…DQY · Traditional | 02/23/2004SE |
| K022138 | Spectranetics 0.035 Support Catheter, Model 518-028DQY · Traditional | 09/23/2002SE |
| K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support…DQY · Traditional | 11/16/1999SE |
| K990713 | Spectranetics Lead Locking Device (LLD) #1, #2, #3 ListerDRB · Traditional | 10/22/1999SE |
PMA approvals
- P160049 Stellarex 0.035 Otw Drug-Coated Angioplasty Balloon · 07/26/2017 · 24 supplements
- P050018 Angiosculpt Scoring Balloon Catheter · 01/08/2007 · 32 supplements
- P910001 Spectranectics CVX-300 Excimer Laser System · 02/19/1993 · 114 supplements
- P900032 Ais Eximer Laser Angioplasty · 01/31/1992 · 10 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1070-2025 Class I | Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack…Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by… | 01/10/2025Open, Classified |
| Z-0680-2025 Class II | Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description…Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining… | 11/25/2024Open, Classified |
| Z-0509-2024 Class II | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics…Incorrect product labeling. Exterior product box label does not match internal pouch label. | 11/15/2023Open, Classified |
| Z-0221-2023 Class II | Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures…Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter… | 10/14/2022Open, Classified |
| Z-1351-2022 Class II | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon…The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an… | 06/01/2022Open, Classified |
| Z-2143-2020 Class II | Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire…There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long… | 03/31/2020Terminated |
| Z-0576-2020 Class II | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm…The incorrect outer carton box was used for the product. | 12/07/2018Terminated |
| Z-3106-2017 Class I | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire…Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential… | 08/07/2017Terminated |
| Z-2863-2017 Class II | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters…Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy… | 06/06/2017Terminated |
| Z-0663-2017 Class II | Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… | 10/31/2016Terminated |
| Z-0662-2017 Class II | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… | 10/31/2016Terminated |
| Z-0661-2017 Class II | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… | 10/31/2016Terminated |
| Z-0758-2016 Class II | 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System…The product is labeled with an expiration date that is past its shelf life. | 01/15/2016Terminated |
| Z-1395-2012 | 12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to…Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket. | 03/13/2012Terminated |
| Z-2952-2011 | Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO…Packaging integrity may be compromised, thus sterility can not be assured. | 07/18/2011Terminated |
| Z-2951-2011 | Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO…Packaging integrity may be compromised, thus sterility can not be assured. | 07/18/2011Terminated |
| Z-2190-2010 | Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R…Guidewire lumen may be occluded, preventing guidewire insertion into the catheter. | 07/01/2010Terminated |
| Z-1264-2009 | Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter…Catheter outer jacket may split during use. | 03/16/2009Terminated |
| Z-0903-2009 | Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually…Catheter pouch was mislabeled with the wrong size. | 10/15/2008Terminated |
| Z-0976-2009 | Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr…The catheter pouch label was incorrectly labeled with the wrong size. | 07/04/2008Terminated |
| Z-0698-2008 | Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile…Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the… | 12/10/2007Terminated |