Submission Details
| 510(k) Number | K180694 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 16, 2018 |
| Decision Date | April 05, 2018 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Apr 2018
Decision
20d
Days
Class 2
Risk
About This 510(k) Submission
K180694 is an FDA 510(k) clearance for the Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters, 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 April 5, 2018, 20 days after receiving the submission on March 16, 2018. 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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