Data / Medical devices / United States / Spectranetics Corp.
Spectranetics Corp.: FDA-registered device maker in Colorado Springs, CO, United States, 28 510(k) clearances and 2 PMA approvals
Spectranetics Corp. is registered with the FDA (registration 3007284006) in Colorado Springs, CO, United States. It lists 12 device types. The FDA files 28 510(k) clearances and 2 PMA approvals under its listings, the newest dated June 24, 2025. 17 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007284006
- Address
- 9965 Federal Drive, Colorado Springs, CO, United States, 80921
- Owner or operator
- Philips Medical Systems International BV (2939520)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 21, 2015
- Registered through
- 2026
- Brand names listed
- Bridge Occlusion Balloon, Bridge Plus Occlusion Balloon Catheter, Bridge Prep Kit, CVX-300 Excimer Laser System, CavaClear Laser Sheath, ELCA Coronary Laser Atherectomy Catheter, GlideLight Laser Sheath, LLD E Lead Locking Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter For Crossing Total Occlusions | PDU | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter Introducer Kit | OFC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Device, Angioplasty, Laser, Coronary | LPC | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Removal, Pacemaker Electrode, Percutaneous | MFA | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Laser-Powered Inferior Vena Cava Filter Retrieval Catheter | QRJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stylet, Catheter | DRB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2025 | K251358 | Bridge Plus Occlusion Balloon (590-002) | MJN | Substantially Equivalent | Philips Image Guided Therapy Devices | accessdata.fda.gov |
| March 13, 2025 | K250385 | Turbo-Elite Laser Atherectomy Catheter | MCW | Substantially Equivalent | Spectranetics | accessdata.fda.gov |
| December 8, 2022 | K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | MCW | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| December 21, 2021 | DEN210024 | CavaClear Laser Sheath | QRJ | Unknown | Spectranetics, Inc. | accessdata.fda.gov |
| June 14, 2021 | K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | MCW | Substantially Equivalent | Volcano Atheromed, Inc. | accessdata.fda.gov |
| December 23, 2020 | K203540 | Bridge Occlusion Balloon | MJN | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| December 20, 2018 | K182972 | Phoenix Atherectomy System | MCW | Substantially Equivalent | Volcano Atheromed, Inc. | accessdata.fda.gov |
| April 5, 2018 | K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | MCW | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| August 24, 2017 | K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System | MCW | Substantially Equivalent | Volcano Atheromed, Inc. | accessdata.fda.gov |
| April 7, 2017 | K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | MCW | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| July 8, 2016 | K161333 | TightRail Sub-C Rotating Dilator Sheath | DRE | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| February 5, 2016 | K153530 | Bridge Occlusion Balloon | MJN | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| May 26, 2015 | K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | MCW | Substantially Equivalent | Volcano Atheromed, Inc. | accessdata.fda.gov |
| March 4, 2015 | K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | DRE | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| February 27, 2015 | K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter | DQY | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| December 19, 2014 | K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip | MCW | Substantially Equivalent | Volcano Atheromed, Inc. | accessdata.fda.gov |
| August 22, 2014 | K140944 | 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP | MCW | Substantially Equivalent | Atheromed, Inc. | accessdata.fda.gov |
| August 12, 2014 | K142116 | LLD EZ | DRB | Substantially Equivalent | Spectranetics, Inc. | accessdata.fda.gov |
| January 25, 2013 | K123632 | 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 | MCW | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
| March 26, 2010 | K093257 | TORQMAX SHEATH GRIP ACCESSORY | OFC | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
| November 2, 2009 | K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH | DRE | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
| March 28, 2008 | K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 | QEZ | Substantially Equivalent | Kensey Nash Corp. | accessdata.fda.gov |
| February 26, 2008 | K080144 | MANDREL GUIDEWIRES OR M-WIRES | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| December 4, 2007 | K072750 | SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 | DQY | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
| July 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 | PDU | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
| March 16, 2005 | K043401 | SPECTRANETICS LLD CS, MODEL 518-039 | DRB | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
| February 23, 2004 | K033678 | SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 | DQY | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
| October 22, 1999 | K990713 | SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER | DRB | Substantially Equivalent | Spectranetics Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 9, 1997 | P960042 | SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH | MFA | 67 | December 18, 2025 | accessdata.fda.gov |
| February 19, 1993 | P910001 | SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM | LPC | 114 | August 21, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 10, 2025 | 96097 | Class I | Ongoing | Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90c | Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, uninte | accessdata.fda.gov |
| November 25, 2024 | 95815 | Class II | Ongoing | Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description / 989930000531 / 1.4 mm OTW / 989930000551 / 1.7 mm OTW / 989930000571 / 2.0 mm OTW / 989930000591 / 2.3 mm OTW / 989930000601 / 2.5 | Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. | accessdata.fda.gov |
| November 15, 2023 | 93373 | Class II | Ongoing | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF Spectranetics Turbo-Elite L | Incorrect product labeling. Exterior product box label does not match internal pouch label. | accessdata.fda.gov |
| October 14, 2022 | 90971 | Class II | Ongoing | Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads. | Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient. | accessdata.fda.gov |
| June 1, 2022 | 90364 | Class II | Ongoing | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM | The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared. | accessdata.fda.gov |
| March 31, 2020 | 85477 | Class II | Terminated | Bridge Occlusion Balloon, REF, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 008131320 | There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too lo | accessdata.fda.gov |
| August 7, 2017 | 77934 | Class I | Terminated | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device us | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. | accessdata.fda.gov |
| June 6, 2017 | 77474 | Class II | Terminated | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions | Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner. | accessdata.fda.gov |
| October 31, 2016 | 75617 | Class II | Terminated | Turbo Elite Atherectomy Catheter. Models:,,,,,,,,, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivesse | Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging. | accessdata.fda.gov |
| January 15, 2016 | 73098 | Class II | Terminated | 2.3mm Turbo-Power OTW, Manual, Model No Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Ather | The product is labeled with an expiration date that is past its shelf life. | accessdata.fda.gov |
| March 13, 2012 | 61408 | Not yet classified | Terminated | 12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads const | Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket. | accessdata.fda.gov |
| July 18, 2011 | 59382 | Not yet classified | Terminated | Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for u | Packaging integrity may be compromised, thus sterility can not be assured. | accessdata.fda.gov |
| July 1, 2010 | 56115 | Not yet classified | Terminated | Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels. | Guidewire lumen may be occluded, preventing guidewire insertion into the catheter. | accessdata.fda.gov |
| March 16, 2009 | 51438 | Not yet classified | Terminated | Spectranetics SLS II Laser Sheath Kit, 14F, REF, Individually packaged catheter introducer. | Catheter outer jacket may split during use. | accessdata.fda.gov |
| October 15, 2008 | 50512 | Not yet classified | Terminated | Spectranetics SLS II 14Fr. Laser Sheath Kit, REF, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facil | Catheter pouch was mislabeled with the wrong size. | accessdata.fda.gov |
| July 4, 2008 | 50548 | Not yet classified | Terminated | Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907. The pouch label of the 1.4mm TE Over the Wire (O | The catheter pouch label was incorrectly labeled with the wrong size. | accessdata.fda.gov |
| December 10, 2007 | 45949 | Not yet classified | Terminated | Spectranetics Quick-Cross Support Catheters,.035in x 90cm, REF#:, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907. | Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number, 135 cm--the exterior box labeling is correct as 90 cm. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Catheter, Peripheral, Atherectomy
- All makers of Catheter, Percutaneous
- All makers of Catheter For Crossing Total Occlusions
- All makers of Catheter, Intravascular Occluding, Temporary
Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.