Company ยท US
Spectranetics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2025. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 15 |
| DQY | Catheter, Percutaneous | 14 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 9 |
| PDU | Catheter For Crossing Total Occlusions | 7 |
| MJN | Catheter, Intravascular Occluding, Temporary | 5 |
| LPC | Device, Angioplasty, Laser, Coronary | 4 |
| DRB | Stylet, Catheter | 3 |
| OEX | Cardiovascular Catheter Sheath Introducer Kit | 2 |
| DXE | Catheter, Embolectomy | 1 |
| MJQ | 1 | |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | 1 |
| OFC | Catheter Introducer Kit | 1 |
| QCT | Scaffold, Dissection Repair | 1 |
| QRJ | Laser-Powered Inferior Vena Cava Filter Retrieval Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 13, 2025 | K250385 | Turbo-Elite Laser Atherectomy Catheter Spectranetics | MCW |
| Dec 15, 2022 | K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French Spectranetics, Inc. | DRE |
| Dec 8, 2022 | K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. | MCW |
| Aug 24, 2022 | K212784 | TightRail Guardian Motorized Dilator Sheath Spectranetics, Inc. | DRE |
| Dec 21, 2021 | DEN210024 | CavaClear Laser Sheath Spectranetics, Inc. | QRJ |
| Dec 23, 2020 | K203540 | Bridge Occlusion Balloon Spectranetics, Inc. | MJN |
| Apr 5, 2018 | K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. | MCW |
| Nov 27, 2017 | K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. | MCW |
| Apr 7, 2017 | K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters Spectranetics, Inc. | MCW |
| Jan 5, 2017 | K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters Spectranetics, Inc. | MCW |
| Jul 8, 2016 | K161333 | TightRail Sub-C Rotating Dilator Sheath Spectranetics, Inc. | DRE |
| Feb 5, 2016 | K153530 | Bridge Occlusion Balloon Spectranetics, Inc. | MJN |
| Nov 12, 2015 | K152181 | Turbo-Power Laser Atherectomy Catheter Spectranetics, Inc. | MCW |
| Mar 4, 2015 | K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath Spectranetics, Inc. | DRE |
| Feb 27, 2015 | K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter Spectranetics, Inc. | DQY |
| Sep 25, 2014 | K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath Spectranetics, Inc. | DRE |
| Aug 12, 2014 | K142116 | LLD EZ Spectranetics, Inc. | DRB |
| Jul 23, 2014 | K140775 | TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM Spectranetics Corporation | MCW |
| May 23, 2014 | K141131 | TIGHTRAIL MINI Spectranetics, Inc. | DRE |
| Apr 9, 2014 | K140047 | LEXICONTURE MECHANICAL DILATOR SHEATH SET Spectranetics Corp. | DRE |
| Mar 27, 2014 | K133631 | LEXIPLIANT DILATOR SHEATH SET Spectranetics Corporation | DRE |
| Jan 25, 2013 | K123632 | 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 Spectranetics Corp. | MCW |
| Oct 17, 2011 | K112032 | 8FR TURBO - TANDEM SYSTEM Spectranetics Corp. | DQY |
| Mar 26, 2010 | K093257 | TORQMAX SHEATH GRIP ACCESSORY Spectranetics Corp. | OFC |
| Jan 25, 2010 | K094036 | TURBO-TANDEM SYSTEM MODEL 472-110 Spectranetics Corp. | MCW |
| Nov 2, 2009 | K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH Spectranetics Corp. | DRE |
| Sep 4, 2009 | K092396 | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS Spectranetics Corp. | DQY |
| Jul 1, 2009 | K091299 | SPECTRANETICS TURBO-TANDEM SYSTEM Spectranetics Corp. | DQY |
| May 4, 2009 | K090913 | CROSS-PILOT TURBO ELITE SUPPORT CATHETER Spectranetics Corp. | DQY |
| Dec 11, 2008 | K082559 | SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER Spectranetics Corp. | DQY |
| Dec 10, 2008 | K082561 | SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS Spectranetics Corp. | DQY |
| Dec 4, 2007 | K072750 | SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 Spectranetics Corp. | DQY |
| 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 |
| 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 |
| Sep 2, 2005 | K052296 | CLIRPATH TURBO EXCIMER LASER CATHETERS Spectranetics Corp. | PDU |
| Aug 18, 2005 | K043465 | 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 Spectranetics Corp. | PDU |
| Mar 16, 2005 | K043401 | SPECTRANETICS LLD CS, MODEL 518-039 Spectranetics Corp. | DRB |
| Apr 27, 2004 | K040067 | CLIRPATH EXCIMER LASER CATHETER Spectranetics Corp. | PDU |
| Feb 23, 2004 | K033678 | SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 Spectranetics Corp. | DQY |
| Sep 23, 2002 | K022138 | SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 Spectranetics Corp. | DQY |
| Nov 16, 1999 | K991059 | SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 Spectranetics Corp. | DQY |
| Oct 22, 1999 | K990713 | SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER Spectranetics Corp. | DRB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2025 | Spectranetics Corporation 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; T Open, Classified |
QCT | None listed |
| Dec 16, 2024 | Spectranetics Corporation 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- Open, Classified |
MCW | K123632 K170059 |
| Dec 8, 2023 | Spectranetics Corporation 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 Open, Classified |
MCW | K170059 |
| Nov 11, 2022 | Spectranetics Corporation 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 Open, Classified |
LPC | None listed |
| Jun 1, 2022 | Spectranetics Corporation Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM Open, Classified |
LPC | None listed |
| Mar 31, 2020 | Spectranetics Corporation 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 Markin Terminated |
MJN | K153530 |
| Dec 7, 2018 | Spectranetics Corporation 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, Fremon Terminated |
NWX | None listed |
| Aug 26, 2017 | Spectranetics Corporation 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 U Terminated |
MJN | K153530 |
| Jul 14, 2017 | Spectranetics Corporation 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 Terminated |
MCW | K170059 |
| Nov 28, 2016 | Spectranetics Corporation 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 procedu Terminated |
MJN | K140775 |
| Nov 28, 2016 | Spectranetics Corporation 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 Syste Terminated |
LPC | K140775 |
| Nov 28, 2016 | Spectranetics Corporation 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 Terminated |
MCW | K140775 |
| Feb 5, 2016 | Spectranetics Corp. 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. Terminated |
MCW | K152181 |
| Apr 11, 2012 | Spectranetics Corp. 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 defib Terminated |
LPC | None listed |
| Aug 4, 2011 | Spectranetics Corporation 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 Spectr Terminated |
DQY | K071226 |
| Aug 4, 2011 | Spectranetics Corporation 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 Spectr Terminated |
DQY | K071226 |
| Aug 9, 2010 | Spectranetics Corporation Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels. Terminated |
DXE | K060092 K073519 |
| Jun 1, 2009 | Spectranetics Corporation Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer. Terminated |
OEX | None listed |
| Feb 11, 2009 | Spectranetics Corporation Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907.
The pouch label of Terminated |
MJQ | K071227 |
| Jan 30, 2009 | Spectranetics Corporation 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 introdu Terminated |
OEX | None listed |
| Feb 5, 2008 | Spectranetics Corporation Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907. Terminated |
DQY | None listed |