Submission Details
| 510(k) Number | K152181 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 04, 2015 |
| Decision Date | November 12, 2015 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Turbo-Power Laser Atherectomy Catheter
Nov 2015
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K152181 is an FDA 510(k) clearance for the Turbo-Power Laser Atherectomy Catheter, 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 November 12, 2015, 100 days after receiving the submission on August 4, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.
Device Classification
| Product Code | MCW — Catheter, Peripheral, Atherectomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4875 |
Manufacturer
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