Spectranetics Corp.
Fremont, CA, US
SPECTRANETICS CORP. appears in FDA device records in Fremont, CA. FDA records list 57 510(k) clearances between and , 183 PMA records and 2 registered establishments. As of , FDA records show 28 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Spectranetics Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Angioscore, Inc.510(k), recall
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Spectranetics Corp. between 1999 and 2025. The busiest year on record is 2014, with 7. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2002 | 1 |
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 5 |
| 2009 | 5 |
| 2010 | 4 |
| 2011 | 3 |
| 2013 | 2 |
| 2014 | 7 |
| 2015 | 4 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250385 | Turbo-Elite Laser Atherectomy Catheter | MCW | Substantially Equivalent | |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) | DRE | Substantially Equivalent | |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | MCW | Substantially Equivalent | |
| K212784 | TightRail Guardian Motorized Dilator Sheath | DRE | Substantially Equivalent | |
| DEN210024 | CavaClear Laser Sheath | QRJ | Unknown | |
| K203540 | Bridge Occlusion Balloon | MJN | Substantially Equivalent | |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | MCW | Substantially Equivalent | |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | MCW | Substantially Equivalent | |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | MCW | Substantially Equivalent | |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters | MCW | Substantially Equivalent | |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | DRE | Substantially Equivalent | |
| K153530 | Bridge Occlusion Balloon | MJN | Substantially Equivalent | |
| K152181 | Turbo-Power Laser Atherectomy Catheter | MCW | Substantially Equivalent | |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | DRE | Substantially Equivalent | |
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | PNO | Substantially Equivalent | |
| K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter | DQY | Substantially Equivalent | |
| K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath | DRE | Substantially Equivalent | |
| K142116 | LLD EZ | DRB | Substantially Equivalent | |
| K140775 | TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM | MCW | Substantially Equivalent | |
| K141131 | TIGHTRAIL MINI | DRE | Substantially Equivalent | |
| K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING | PNO | Substantially Equivalent | |
| K140047 | LEXICONTURE MECHANICAL DILATOR SHEATH SET | DRE | Substantially Equivalent | |
| K133631 | LEXIPLIANT DILATOR SHEATH SET | DRE | Substantially Equivalent | |
| K123632 | 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 | MCW | Substantially Equivalent | |
| K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | Substantially Equivalent | |
| K112032 | 8FR TURBO - TANDEM SYSTEM | DQY | Substantially Equivalent | |
| K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | Substantially Equivalent | |
| K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | Substantially Equivalent | |
| K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY | PNO | Substantially Equivalent | |
| K093257 | TORQMAX SHEATH GRIP ACCESSORY | OFC | Substantially Equivalent | |
| K100303 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY | PNO | Substantially Equivalent | |
| K094036 | TURBO-TANDEM SYSTEM MODEL 472-110 | MCW | Substantially Equivalent | |
| K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH | DRE | Substantially Equivalent | |
| K092396 | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS | DQY | Substantially Equivalent | |
| K091966 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 | PNO | Substantially Equivalent | |
| K091299 | SPECTRANETICS TURBO-TANDEM SYSTEM | DQY | Substantially Equivalent | |
| K090913 | CROSS-PILOT TURBO ELITE SUPPORT CATHETER | DQY | Substantially Equivalent | |
| K082559 | SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER | DQY | Substantially Equivalent | |
| K082561 | SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS | DQY | Substantially Equivalent | |
| K082059 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | Substantially Equivalent | |
| K081220 | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | Substantially Equivalent | |
| K080151 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 | PNO | Substantially Equivalent | |
| K072750 | SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 | DQY | Substantially Equivalent | |
| K072225 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | PNO | Substantially Equivalent | |
| 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 | |
| K071226 | 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 | PDU | Substantially Equivalent | |
| K060012 | CLIRPATH TURBO PERIPHERAL CATHETERS | PDU | Substantially Equivalent | |
| K052514 | CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 | PDU | Substantially Equivalent | |
| K052296 | CLIRPATH TURBO EXCIMER LASER CATHETERS | PDU | Substantially Equivalent | |
| K050629 | ANGIOSCULPT SCORING BALLOON CATHETER | PNO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005462046 | 3005462046 | SPECTRANETICS CORP. | 5055 BRANDIN COURT, FREMONT, CA 94538 US | 2026 | |
| 3007284006 | 3007284006 | SPECTRANETICS CORP. | 9965 Federal Drive, Colorado Springs, CO 80921 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QEZAspiration Thrombectomy Catheter
- PDUCatheter For Crossing Total Occlusions
- OFCCatheter Introducer Kit
- MJNCatheter, Intravascular Occluding, Temporary
- DQYCatheter, Percutaneous
- NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
- PNOCatheter, Percutaneous, Cutting/Scoring
- MCWCatheter, Peripheral, Atherectomy
- LPCDevice, Angioplasty, Laser, Coronary
- MFADevice, Removal, Pacemaker Electrode, Percutaneous
- DREDilator, Vessel, For Percutaneous Catheterization
- ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter
- QRJLaser-Powered Inferior Vena Cava Filter Retrieval Catheter
- DRBStylet, Catheter
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 28| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1070-2025 | 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, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062 | 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, unintended removal of tack devices, and ischemia. | Class I | Open, Classified | |
| Z-0680-2025 | Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans. | 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. | Class II | Open, Classified | |
| Z-0509-2024 | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans. | Incorrect product labeling. Exterior product box label does not match internal pouch label. | Class II | Open, Classified | |
| Z-0221-2023 | 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. | Class II | Open, Classified | |
| Z-1351-2022 | 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. | Class II | Open, Classified | |
| Z-2143-2020 | Bridge Occlusion Balloon, REF 590-001, 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: 00813132024666 | 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 long it could lead to embolization. | Class II | Terminated | |
| Z-0576-2020 | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA. | The incorrect outer carton box was used for the product. | Class II | Terminated | |
| Z-3106-2017 | 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 used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. | Class I | Terminated | |
| Z-2863-2017 | 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. | Class II | Terminated | |
| Z-0663-2017 | Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended. | 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. | Class II | Terminated | |
| Z-0662-2017 | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 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 multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. | 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. | Class II | Terminated | |
| Z-0661-2017 | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 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 multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. | 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. | Class II | Terminated | |
| Z-0758-2016 | 2.3mm Turbo-Power OTW, Manual, Model No 423-050 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 Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System. | The product is labeled with an expiration date that is past its shelf life. | Class II | Terminated | |
| Z-1395-2012 | 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 constructed with silicone or polyurethane outer insulation. | Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket. | Terminated | ||
| Z-2952-2011 | Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. | Packaging integrity may be compromised, thus sterility can not be assured. | Terminated | ||
| Z-2951-2011 | Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907. Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. | Packaging integrity may be compromised, thus sterility can not be assured. | Terminated | ||
| Z-0842-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020 | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | Terminated | ||
| Z-0841-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020. | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | Terminated | ||
| Z-0840-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020. | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | Terminated | ||
| Z-0839-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020. | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | Terminated | ||
| Z-0838-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020 | Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism. | Terminated | ||
| Z-2190-2010 | 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. | Terminated | ||
| Z-2218-2010 | AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use. | Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments. | Terminated | ||
| Z-1264-2009 | Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer. | Catheter outer jacket may split during use. | Terminated | ||
| Z-0903-2009 | Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. | Catheter pouch was mislabeled with the wrong size. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain