Spectranetics · Class II · Cleared Mar 13, 2025
| K-number | K250385 |
| Device name | Turbo-Elite Laser Atherectomy Catheter |
| Applicant | Spectranetics |
| Product code | MCW |
| Device class | Class II |
| Decision date | Mar 13, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.4875 |
The Turbo-Elite Laser Atherectomy Catheter is a percutaneous intravascular device that delivers ultraviolet energy from a laser system to dissolve arterial blockages through photoablation. It is indicated for treatment of infrainguinal stenoses and occlusions, and for treating femoropopliteal artery in-stent restenosis when used with the Turbo-Tandem System and PTA.
The subject device has identical technological characteristics to the predicate, with the same dimensional criteria, materials of construction (inner lumens, outer jackets, hydrophilic coating, epoxy), outer diameter, working length, and guidewire compatibility. Minor updates to Instructions for Use included new warnings about fluoroscopic monitoring and marker band detachment detection, while component supplier and adhesive changes were validated through design verification and validation testing.
Not stated in this summary.
The subject device is substantially equivalent because it has the same indications for use, transmits UV energy via identical fiber optic construction to photoablate lesions, maintains all the same dimensional specifications and material composition as the predicate, and operates through the same mechanism of action. Material and supplier changes were supported by design verification and validation testing, demonstrating no significant impact on device technology, engineering, or performance.
View the full FDA submission: accessdata.fda.gov