510(k) K152181 ยท MCW Catheter, Peripheral, Atherectomy
Turbo-Power Laser Atherectomy Catheter
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Nov 12, 2015 |
| Received | Aug 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152181
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.