Spectranetics, Inc. · Class II · Cleared Apr 5, 2018
| K-number | K180694 |
| Device name | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
| Applicant | Spectranetics, Inc. |
| Product code | MCW |
| Device class | Class II |
| Decision date | Apr 5, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 870.4875 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov