K162561 is an FDA 510(k) clearance for the Turbo-Power (2.0mm) Laser Atherectomy Catheters. This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on January 5, 2017, 113 days after receiving the submission on September 14, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K162561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2016 |
| Decision Date | January 05, 2017 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MCW — Catheter, Peripheral, Atherectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4875 |