Spectranetics Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 12 (2 Class I)
- 510(k) Clearances
- 2
- Inspections
- 18
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1070-2025 | Class I | Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) followi | January 10, 2025 |
| Z-0680-2025 | Class II | Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / | November 25, 2024 |
| Z-0509-2024 | Class II | Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite | November 15, 2023 |
| Z-0221-2023 | Class II | Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the | October 14, 2022 |
| Z-1351-2022 | Class II | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 1 | June 1, 2022 |
| Z-2143-2020 | Class II | Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.03 | March 31, 2020 |
| Z-0576-2020 | Class II | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon lengt | December 7, 2018 |
| Z-3106-2017 | Class I | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0 | August 7, 2017 |
| Z-2863-2017 | Class II | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is | June 6, 2017 |
| Z-0662-2017 | Class II | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 12 | October 31, 2016 |
| Z-0663-2017 | Class II | Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in ap | October 31, 2016 |
| Z-0661-2017 | Class II | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420- | October 31, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140775 | TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM | July 23, 2014 |
| K133631 | LEXIPLIANT DILATOR SHEATH SET | March 27, 2014 |